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PubMed2000

Adjuvant chemotherapy for localised resectable soft tissue sarcoma in adults. Sarcoma Meta-analysis Collaboration (SMAC).

BACKGROUND: Individually, randomised trilas have not shown conclusively whether adjuvant chemotherapy benefits adult patients with localised resectable soft-tissue sarcoma. OBJECTIVES: Adjuvant chemotherapy aims to lessen the recurrence of cancer after surgery with or without radiotherapy. The objective of this review was to assess the effects of adjuvant chemotherapy in adults with resectable soft tissue sarcoma after such local treatment. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, UKCCCR Register of Cancer Trials, Physicians Data Query, EMBASE, MEDLINE and CancerLit. SELECTION CRITERIA: Randomised trials of adjuvant chemotherapy after local treatment in adults with localised resectable soft tissue sarcoma were included. Only trials in which accrual was completed by December 1992 were included. DATA COLLECTION AND ANALYSIS: Individual patient data were obtained. Accuracy of data and quality of randomisation and follow-up of trials was assessed. MAIN RESULTS: Fourteen trials of doxorubicin-based adjuvant chemotherapy involving 1568 patients were included. Median follow-up was 9.4 years. For local recurrence-free interval the hazard ratio with chemotherapy was 0.73 (95% Confidence Interval 0.56-0.94). For distant recurrence-free interval it was 0. 70 (95% CI 0.57-0.85). For overall recurrence-free survival it was 0. 75 (95% CI 0.64-0.87). These correspond to significant absolute benefits of 6-10% at 10 years. For overall survival the hazard ratio of 0.89 (95% CI 0.76-1.03) was not significant but potentially represents an absolute benefit of 4% (95% CI -1 to 9) at 10 years. There was no consistent evidence of a difference in effect according to age, sex, stage, site, grade, histology, extent of resection, tumour size or exposure to radiotherapy. However, the strongest evidence of a beneficial effect on survival was shown in patients with sarcoma of the extremities. REVIEWER'S CONCLUSIONS: Doxorubicin-based adjuvant chemotherapy appears to significantly improve time to local and distant recurrence and overall recurrence-free survival in adults with localised resectable soft tissue sarcoma. There is some evidence of a trend towards improved overall survival.

Adult↗
PubMed1995

Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma.

BACKGROUND: High-dose chemotherapy followed by autologous bone marrow transplantation is a therapeutic option for patients with chemotherapy-sensitive non-Hodgkin's lymphoma who have relapses. In this report we describe a prospective randomized study of such treatment. METHOD: A total of 215 patients with relapses of non-Hodgkin's lymphoma were treated between July 1987 and June 1994. All patients received two courses of conventional chemotherapy. The 109 patients who had a response to chemotherapy were randomly assigned to receive four courses of chemotherapy plus radiotherapy (54 patients) or radiotherapy plus intensive chemotherapy and autologous bone marrow transplantation (55 patients). RESULTS: The overall rate of response to conventional chemotherapy was 58 percent; among patients with relapses after chemotherapy, the response rate was 64 percent, and among those with relapses during chemotherapy, the response rate was 21 percent. There were three deaths from toxic effects among the patients in the transplantation group, and none among those in the group receiving chemotherapy without transplantation. The two groups did not differ in terms of prognostic factors. The median follow-up time was 63 months. The response rate was 84 percent after bone marrow transplantation and 44 percent after chemotherapy without transplantation. At five years, the rate of event-free survival was 46 percent in the transplantation group and 12 percent in the group receiving chemotherapy without transplantation (P = 0.001), and the rate of overall survival was 53 and 32 percent, respectively (P = 0.038). CONCLUSIONS: As compared with conventional chemotherapy, treatment with high-dose chemotherapy and autologous bone marrow transplantation increases event-free and overall survival in patients with chemotherapy-sensitive non-Hodgkin's lymphoma in relapse.

Adolescent↗
PubMed2004

Health-related quality of life after chemotherapy for advanced germ cell tumors: a comparison of standard-dose and high-dose chemotherapy.

BACKGROUND: The objective of this study was to evaluate the health-related quality of life (HRQoL) in patients with germ cell tumors who received standard-dose chemotherapy or high-dose chemotherapy combined with peripheral blood stem cell transplantation (PBSCT), and to compare the HRQoL of these patients with patients who had undergone surveillance therapy only. METHODS: Among the 102 patients included in this study, 38 underwent standard-dose cisplatin-based combination chemotherapy alone, 24 received high-dose chemotherapy with PBSCT following standard-dose chemotherapy, and 40 underwent surveillance monitoring. HRQoL was evaluated using the SF-36 survey, which contains 36 questions that assess eight quality-of-life aspects, including physical functioning, role-physical functioning, bodily pain, general health, vitality, social functioning, role-emotional functioning and mental health. RESULTS: The follow-up period of the surveillance group was significantly longer than that of the remaining two groups receiving chemotherapy; however, scale scores were not affected by the duration of follow up in either group. No significant difference was observed in any scale scores between the patients undergoing chemotherapy and those in the surveillance group. In comparison with the general population in the USA, social functioning in both the chemotherapy and surveillance groups was significantly lower, whereas vitality in these two groups was significantly higher. Patients undergoing standard-dose chemotherapy alone had a significantly higher score for mental health than those undergoing high-dose chemotherapy. However, there were no significant differences in the remaining seven scores, irrespective of the type of chemotherapy. CONCLUSIONS: Seven of the eight scale scores of HRQoL were favorable in patients who received chemotherapy or surveillance, and no significant difference was observed between these two groups. Moreover, with the exception of the mental health score, HRQoL was not significantly affected by the type of chemotherapy. Therefore, patients who received chemotherapy, including high-dose chemotherapy with PBSCT, seem to be generally satisfied with their overall HRQoL.

Adult↗
PubMed2001

Chemotherapy plus interferon-alpha2b versus chemotherapy in the treatment of follicular lymphoma.

The best treatment of follicular lymphoma remains to be determined because the long natural history of follicular lymphoma requires mature data for accurate analysis. Although the goal of primary treatment remains durable remission, the sequential application of effective treatments may also result in a prolongation of median survival time. The use of interferon (IFN) with doxorubicin-based chemotherapy has demonstrated an increase of event-free survival but not in overall survival; however, its acute and late cardiac toxicity limits its use. For this reason, we began a controlled clinical trial to assess the efficacy and toxicity of chemotherapy: COPP (cyclophosphamide, vincristine, prednisone, and procarbazine) + IFN alternating every month for six cycles compared to six cycles of chemotherapy. In an intent-to treat analysis, 55 patients were enrolled (median age 61 years). Most cases (91%) with advanced disease were randomly assigned to chemotherapy + IFN (28 cases) or chemotherapy (27 cases). Complete remission was observed in 16 patients: 59% (95% CI, 53-70%) in the chemotherapy arm compared to 20 patients 71% (95% CI, 58-79%) in the chemotherapy + IFN arm; total responses were 74% and 86%, respectively. At a median follow-up of 60 months, event-free survival was 100% for patients treated with chemotherapy + IFN, which was statistically different from patients treated with chemotherapy 70%. At 7 years, median survival has not yet been reached; 72% of patients chemotherapy + IFN remain alive without disease (95% CI, 59-81%), which is not statistically different from 72% (95%CI, 50-73%) in the chemotherapy arm. Non-hematological toxicity was most frequent and severe in the chemotherapy arm; hematological toxicity was similar in both groups. Thus, it appears that chemotherapy + IFN, as described herein, improves event-free survival but the overall survival rates remain unchanged. The use of COPP appears to be better that anthracycline-based chemotherapy because it avoids the presence of acute and late cardiac toxicity.

Adult↗
PubMed2005

[Comparison of therapeutical effect between arterial interventional chemotherapy and venous chemotherapy on bulky or locally advanced cervical cancer].

OBJECTIVE: To investigate the therapeutical effect of arterial interventional chemotherapy and venous chemotherapy on bulky or locally advanced cervical cancer. METHODS: A retrospective study was carried out on 174 patients with bulky or locally advanced cervical cancers admitted to our hospital from Sept 1997 to Sept 2003. The therapeutical, toxic and adverse effects of either arterial interventional or venous chemotherapy were analyzed and compared. RESULTS: Among those 174 patients, 69 were given arterial interventional chemotherapy. Patients with cervical adenocarcinoma received cisplatin, fluorouracil, mitomycin C, and patients with squamous carcinoma of cervix were treated with bleomycin, cisplatin. The effective rate was 81%, and the rate of surgery after chemotherapy was 67%. While in the venous chemotherapy group, 105 patients were treated with the same chemotherapeutical schemes and doses as in arterial interventional chemotherapy group. The effective rate was 83% and the rate of surgery after chemotherapy was 70%. The differences between these two groups showed no significance (P > 0.05). No intolerable toxic and adverse effects were noticed during neoadjuvant chemotherapy. The 3- and 5-year survival rates of arterial interventional chemotherapy group were 76%, 70% respectively, and those of venous chemotherapy group were 78%, 71% respectively, without significant difference (P > 0.05). CONCLUSIONS: Neoadjuvant chemotherapy is a safe and effective means for treating patients with bulky or locally advanced cervical cancer. The therapeutical effects of venous and arterial interventional chemotherapy are similar. And no intolerable toxic and adverse effects were noticed during neoadjuvant chemotherapy. Venous administration is easy and inexpensive and less demanding for special equipment. It shows promising prospect in clinical application.

Adult↗
PubMed2003

Presurgical chemotherapy compared with immediate surgery and adjuvant chemotherapy for nonmetastatic osteosarcoma: Pediatric Oncology Group Study POG-8651.

PURPOSE: Successful therapeutic interventions to prevent disease progression in patients with nonmetastatic osteosarcoma have included surgery with adjuvant chemotherapy. Presurgical chemotherapy has been advocated for these patients because of putative improvement in event-free survival (EFS). The advantages of presurgical chemotherapy include early administration of systemic chemotherapy, shrinkage of primary tumor, and pathologic identification of risk groups. The theoretic disadvantage is that it exposes a large tumor burden to marginally effective chemotherapy. The contribution of chemotherapy and surgery timing has not been tested rigorously. PATIENTS AND METHODS: Between 1986 and 1993, we conducted a prospective trial in patients with nonmetastatic osteosarcoma who were assigned randomly to immediate surgery or presurgical chemotherapy. Except for the timing of surgery (week 0 or 10), patients received 44 weeks of identical combination chemotherapy that included high-dose methotrexate with leucovorin rescue, doxorubicin, cisplatin, bleomycin, cyclophosphamide, and dactinomycin. RESULTS: One hundred six patients were enrolled onto this study. Six were excluded from analysis. Of the remaining 100 patients, 45 were randomly assigned to immediate chemotherapy, and 55 were randomly assigned to immediate surgery. Sixty-seven patients remain disease-free. At 5 years, the projected EFS +/- SE is 65% +/- 6% (69% +/- 8% for immediate surgery and 61% +/- 8% for presurgical chemotherapy; P =.8). The treatment arms had similar incidence of limb salvage (55% for immediate surgery and 50% for presurgical chemotherapy). CONCLUSION: Chemotherapy was effective in both treatment groups. There was no advantage in EFS for patients given presurgical chemotherapy.

Adolescent↗
PubMed2000

Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. Philadelphia Bone Marrow Transplant Group.

BACKGROUND: We conducted a randomized trial in which we compared high-dose chemotherapy plus hematopoietic stem-cell rescue with a prolonged course of monthly conventional-dose chemotherapy in women with metastatic breast cancer. METHODS: Women 18 to 60 years of age who had metastatic breast cancer received four to six cycles of standard combination chemotherapy. Patients who had a complete or partial response to induction chemotherapy were then randomly assigned to receive either a single course of high doses of carboplatin, thiotepa, and cyclophosphamide plus transplantation of autologous hematopoietic stem cells or up to 24 cycles of cyclophosphamide, methotrexate, and fluorouracil in conventional doses. The primary end point was survival. RESULTS: The median follow-up was 37 months. Of 553 patients who enrolled in the study, 58 had a complete response to induction chemotherapy and 252 had a partial response. Of these, 110 patients were assigned to receive high-dose chemotherapy plus hematopoietic stem cells and 89 were assigned to receive conventional-dose chemotherapy. In an intention-to-treat analysis, we found no significant difference in survival overall at three years between the two treatment groups (32 percent in the transplantation group and 38 percent in the conventional-chemotherapy group). There was no significant difference between the two treatments in the median time to progression of the disease (9.6 months for high-dose chemotherapy plus hematopoietic stem cells and 9.0 months for conventional-dose chemotherapy). CONCLUSIONS: As compared with maintenance chemotherapy in conventional doses, high-dose chemotherapy plus autologous stem-cell transplantation soon after the induction of a complete or partial remission with conventional-dose chemotherapy does not improve survival in women with metastatic breast cancer.

Adolescent↗
PubMed2006

[Effect of high-dose chemotherapy with subsequent transplantation of blood-forming cells on left ventricle function in patients with malignant lymphomas treated with doxorubicin in primary chemotherapy].

PURPOSE OF STUDY: The authors examined whether high-dose chemotherapy with hematogenic tissue transplantation might negatively affect function of left ventricle (LV) in oncology patients with malignant lymphomas initially treated with conventional chemotherapy consisting of doxorubicin (DOX) in contrast to patients treated without the transplantation in medium-term follow up. PATIENTS AND METHODOLOGY: The follow up group included 77 patients (39 women/38 men) at the age of 36 +/- 15 (median 30, 16-67 years). All 77 patients were treated with initial chemotherapy with DOX, 22 out of that group later received high-dose chemotherapy with hematogenic tissue transplantation (HTT). 16 (73 %) patients of this subgroup underwent autologous transplantation and 5 (23 %) allogeneic transplantation. One female patient (4 %) underwent both autologous and allogeneic transplantation. The follow up period after completion of initial chemotherapy was 5-10 years (median 6 years). The patients were examined with rest echocardiography before start, after chemotherapy, and during follow-up examination. Spiroergometric test (SET) was only performed at the follow-up examination. RESULTS: Both subgroups showed significant decrease of ejection fraction (EF) after chemotherapy, with further decrease in the control examination period, without mutual difference. While the HTT (HTT+) group showed no EF drop below 50 %, in the non-HTT (HTT-) group EF dropped in two (4 %) patients after chemotherapy and in four (8%) patients at the control examination. Progressing decrease of EF > 10 % was reported with 25 % of the HTT- patients (p < 0.05), but with just 13 % of the HTT+ patients (non-significant). The diastolic insufficiency (DF) was present identically in both groups with 36 % of the patients, which represents a statistically significant increase in comparison to the pre-chemotherapy condition. SET did not show any differences in burden toleration and circulation indicators between the two groups. The drop of pVO2 < 20 ml/kg/min occurred with 22 patients of both groups. Linear regression data analysis revealed existence of a significant relationship between EF change, some diastolic function indicators, pVO2 and cumulative dose of DOX (p < 0.05). The current age significantly and negatively correlated with pVO2 (p < 0.001) and DF indicators (p < 0.001). The follow up period inversely correlates with the changes of EF (p < 0.05) and pVO2 (p < 0.05), not correlating with diastolic function indicators. Multi-variant analysis did not confirm any higher risk of administration of high-dose chemotherapy with HTT for significant drop of EF or its drop down to the pathological zone below 50 % (OR = 0.46; non-significant), for discovery of reduced cardio-pulmonary performance (pVO2 < 20 ml/kg/min) (OR = 0.35; non-significant) or for development of diastolic dysfunction (OR = 1.0; non-significant). CONCLUSIONS: Treatment with high-dose chemotherapy with HTT application within medium-term follow up does not result in any significant systolic or diastolic malfunction of myocardium and deterioration of cardiopulmonary performance in comparison to patients not undergoing this therapy. Treatment with cardiotoxic doxorubicin administered in the context of basic conventional chemotherapy is most likely to be responsible for occurrence of the pathological effects across the followed up group. Length of monitoring is a significant factor correlating with changed ejection fraction. This finding justifies the need for long-term prospective monitoring of ejection fraction of the left ventricle in adult patients treated with cardiotoxic chemotherapy.

Adolescent↗
PubMed2001

Combined chemotherapy and radiotherapy (without surgery) compared with radiotherapy alone in localized carcinoma of the esophagus.

BACKGROUND: Esophageal carcinoma can be managed primarily with either a surgical or radiotherapeutic (non surgical) approach. Strategies to improve the outcome of either modality alone include the use of combined modalities. Combination chemotherapy radiotherapy is one approach that has been explored over the years with increasing application in clinical practice especially in North America. OBJECTIVES: To evaluate the effectiveness of combined chemotherapy and radiotherapy versus radiotherapy alone in the outcome of patients with localized esophageal carcinoma. Outcomes of interest include overall survival, cause specific survival, local recurrence, dysphagia relief, quality of life, acute and chronic toxicities. SEARCH STRATEGY: The Cochrane strategy for identifying randomized trials was combined with MeSH headings including esophageal neoplasms, radiotherapy, chemotherapy combined modality, drug therapy combination. Medline, Cancerlit and Embase were searched using this strategy. In addition, the Cochrane library was also searched. References from relevant articles and personal files were included. SELECTION CRITERIA: Randomized controlled trials in patients with localized esophageal cancer, with one arm employing radiotherapy alone, and one arm employing combination radiotherapy chemotherapy were included. Studies comparing non chemotherapy agents such as pure radiotherapy sensitisers, immunostimulants, planned esophagectomy, were excluded. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent reviewers, and the trial quality was assessed using both the Jadad scoring and Detsky checklist. Sensitivity analysis was planned to explore sources of heterogeneity where heterogeneity existed. The factors hypothesized a priori included combination versus sequential treatment, quality of study, biological effective radiotherapy dose (i.e. Radiotherapy dose) cisplatin versus non cisplatin containing trials, and 5FU versus non 5FU containing trials. Odds Ratio (OR) and 95% confidence limits were used to assess the significance of the difference between the treatment arms. Absolute risk difference and number needed to treat (NNT) were used to express the magnitude of difference where appropriate. MAIN RESULTS: Thirteen randomized trials were included in the analysis. There were eight concomitant and five sequential radiotherapy and chemotherapy (RTCT) studies. The studies were analyzed separately due to observed heterogeneity across all the studies and biological considerations. Concomitant RTCT provided significant overall reduction in mortality at 1 and 2 years. The mortality in the control arms was 67% and 86% respectively. Combined RTCT provided an absolute reduction of mortality by 9% (95% CI 2-17%) and 8% (95% CI 1-17%) respectively. Expressed as NNT, this is 11 and 10 respectively. At longer follow up, the results were heterogeneous, cautioning against pooling of the data. There was a reduction in the overall local recurrence rate. The local recurrence rate for the control arms was in the order of 69%. Combined RTCT provided an absolute reduction of local recurrence rate of 5% (95% CI 4-26%) with a NNT of 7. There was significant increase of severe and life threatening toxicities with a NNH of 6, with this approach. With the sensitivity analysis, there was a suggestion that cisplatin based and 5FU based chemotherapy studies were reasonable regimens to employ when using this strategy. The results from the sequential RTCT studies were heterogeneous and could not be pooled. Factors hypothesized a priori did not identify any single source that could account for a significant component of the heterogeneity. Examining the results individually, there was no data to support clinical benefit. This approach was also accompanied by significant toxicities. REVIEWER'S CONCLUSIONS: When a non-operative approach is selected, then concomitant RTCT is superior to the RT alone. This approach is accompanied by significant toxicities. In patients who are in good general condition, and the risk benefit has been thoroughly discussed with the patient, concomitant RTCT should be considered for the management of esophageal cancer compared with radiotherapy alone.

Combined Modality Therapy↗
PubMed2003

High dose chemotherapy and autologous bone marrow or stem cell transplantation versus conventional chemotherapy for women with early poor prognosis breast cancer.

BACKGROUND: Overall survival rates are disappointing for women with early poor prognosis breast cancer. There is a hypothesis that high dose chemotherapy with autologous bone marrow or stem cell transplant (autograft) may improve survival rates by permitting higher doses of adjuvant chemotherapy to be given. OBJECTIVES: To compare the effectiveness of high dose chemotherapy and autograft versus conventional chemotherapy for women with early poor prognosis breast cancer. SEARCH STRATEGY: We searched the Cochrane Breast Cancer Group specialised register, The Cochrane Controlled Trials Register (Cochrane Library Issue 3, 2002), MEDLINE (1966 to Aug. 2002), EMBASE (1980 to Aug. 2002), PsycINFO (1984 to Aug. 2002), Cinahl (1982 to July 2002), the websites of co-operative research groups and ASCO (American Society of Clinical Oncologists) and reference lists of articles found. SELECTION CRITERIA: Randomised controlled trials comparing the effectiveness of high dose chemotherapy and autograft versus conventional chemotherapy for women with early poor prognosis breast cancer. DATA COLLECTION AND ANALYSIS: We identified nine trials that met the inclusion criteria. Three independent reviewers extracted data. MAIN RESULTS: In total 1758 women were randomised to receive high dose chemotherapy with autograft and 1767 women were randomised to receive conventional chemotherapy. There were 48 non cancer-related deaths on the high dose arm and four on the conventional dose arm (RR 7.74, 95% CI (3.43, 17.50). Since many studies have not completed follow-up, overall survival rates were in most cases based on results to date. There was no statistically significant difference in overall survival between women who received high dose chemotherapy with autograft and women who received conventional chemotherapy, either at three years (RR 1.02, 95% CI (0.98, 1.06)), or at five years (RR 0.98, 95% CI (0.93, 1.05)). There was a statistically significant benefit in event-free survival at three years for the group who received high dose chemotherapy (RR 1.11, 95% CI (1.05, 1.18)). However at five years there was no statistically significant difference between the groups (RR 1.00, 95% CI (0.92, 1.08)). Side-effects were more common and more severe in the high dose group though most were reversible. Women in the high dose group reported significantly worse quality of life scores immediately after treatment but at one year there was no statistically significant difference between the groups in quality of life scores. REVIEWER'S CONCLUSIONS: There is insufficient evidence to support the routine use of high dose chemotherapy with autograft for women with early poor prognosis breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2003

Older age predicts a decline in adjuvant chemotherapy recommendations for patients with breast carcinoma: evidence from a tertiary care cohort of chemotherapy-eligible patients.

BACKGROUND: The appropriate use of adjuvant chemotherapy for elderly women with breast carcinoma remains controversial. Efficacy data in women age >/= 70 years are scarce, resulting in a lack of clear guidelines for patients in this age group. Although several studies have demonstrated decreasing use of chemotherapy with age, none specifically examined its use in an elderly cohort of patients who were deemed eligible for such therapy based on consensus guidelines, simultaneously examining the impact of comorbidity and previous history of malignant disease on these recommendations. METHODS: The authors examined adjuvant chemotherapy use among chemotherapy-eligible patients age > or = 50 years who were evaluated in a tertiary care cancer center. Associations between patient age and 1) physician recommendation for adjuvant chemotherapy, 2) recommended treatment regimen, and 3) patient acceptance of the treatment plan recommended were examined, adjusting for the impact of aggressive tumor characteristics, medical comorbidity, previous history of malignant disease, and features of the treatment setting. RESULTS: Of the 208 chemotherapy-eligible patients who were studied, 74% overall were recommended chemotherapy. Chemotherapy was recommended to 92% of women age 50-59 years compared with 77% of women age 60-69 years and 23% of women age > or = 70 years. Increasing age was associated strongly with a decreasing likelihood of receiving a recommendation in favor of chemotherapy. After adjusting for estrogen receptor status, previous history of malignant disease, comorbidity score, and prognostic group, the odds of receiving a recommendation in favor of chemotherapy fell by 22% per year or 91% per 10-year interval, and the rate of decline did not change significantly at age > or = 70 years. We found no age-related differences in either the drug regimens recommended or patient acceptance rates for adjuvant therapy. CONCLUSIONS: Age was associated strongly and independently with physician recommendation for adjuvant chemotherapy among a group of older women who were eligible specifically for such therapy. Medical comorbidity and a history of previous malignant disease did not alter this correlation significantly, although the latter was a significant predictor of chemotherapy use. Further studies clearly are needed to determine the underlying reasons for this strong age effect and to explore strategies that will optimize the utilization of this potentially curative therapy in the elderly.

Age Factors↗
PubMed2002

Survival of patients with advanced ovarian cancer treated with intermittent chemotherapy following cytoreductive surgery and adjuvant chemotherapy.

BACKGROUND: The purpose of this study was to report the duration of the progression-free interval (PFI) in advanced ovarian cancer patients who were treated with intermittent maintenance chemotherapy. METHODS: Between 1991 and 1998, 25 patients with stage III or IV ovarian cancer were enrolled in a trial of intermittent maintenance chemotherapy. All patients underwent cytoreduction surgery, and received adjuvant chemotherapy, after which they were treated with intermittent maintenance chemotherapy every 3 to 4 months for 2 years. RESULTS: The median PFI in the 25 women in the intermittent chemotherapy group was 25 months, while in the 32 patients in the control group it was 18 months (P = 0.0124). The median survival of women treated with the intermittent chemotherapy was 34 months, and for the control group patients, it was 35 months (P = 0.0672). Multivariate analysis in the intermittent chemotherapy group revealed that the only factor that correlated significantly with PFI was the status after adjuvant chemotherapy (P = 0.0137). In patients with no evidence of disease after the adjuvant chemotherapy, the median survival was 39 months in the intermittent chemotherapy group, and 35 months in the control group (P = 0.0156). The median PFI was 28 months in the intermittent chemotherapy group, and 18 months in the control group (P = 0.0012). CONCLUSION: It would be warranted to perform intermittent maintenance chemotherapy for patients with advanced ovarian cancer, if a clinically disease-free status could be achieved after completion of the standard treatment procedure.

Adenocarcinoma↗
PubMed2000

Chemotherapy added to locoregional treatment for head and neck squamous-cell carcinoma: three meta-analyses of updated individual data. MACH-NC Collaborative Group. Meta-Analysis of Chemotherapy on Head and Neck Cancer.

BACKGROUND: Despite more than 70 randomised trials, the effect of chemotherapy on non-metastatic head and neck squamous-cell carcinoma remains uncertain. We did three meta-analyses of the impact of survival on chemotherapy added to locoregional treatment. METHODS: We updated data on all patients in randomised trials between 1965 and 1993. We included patients with carcinoma of the oropharynx, oral cavity, larynx, or hypopharynx. FINDINGS: The main meta-analysis of 63 trials (10,741 patients) of locoregional treatment with or without chemotherapy yielded a pooled hazard ratio of death of 0.90 (95% CI 0.85-0.94, p<0.0001), corresponding to an absolute survival benefit of 4% at 2 and 5 years in favour of chemotherapy. There was no significant benefit associated with adjuvant or neoadjuvant chemotherapy. Chemotherapy given concomitantly to radiotherapy gave significant benefits, but heterogeneity of the results prohibits firm conclusions. Meta-analysis of six trials (861 patients) comparing neoadjuvant chemotherapy plus radiotherapy with concomitant or alternating radiochemotherapy yielded a hazard ratio of 0.91 (0.79-1.06) in favour of concomitant or alternating radiochemotherapy. Three larynx-preservation trials (602 patients) compared radical surgery plus radiotherapy with neoadjuvant chemotherapy plus radiotherapy in responders or radical surgery and radiotherapy in non-responders. The hazard ratio of death in the chemotherapy arm as compared with the control arm was 1.19 (0.97-1.46). INTERPRETATION: Because the main meta-analysis showed only a small significant survival benefit in favour of chemotherapy, the routine use of chemotherapy is debatable. For larynx preservation, the non-significant negative effect of chemotherapy in the organ-preservation strategy indicates that this procedure must remain investigational.

Antineoplastic Agents↗
PubMed2001

[Influence of chemotherapy on hematopoietic microenvironment and effect of autologous bone marrow stromal cell infusion on the recovery of hematopoiesis after chemotherapy].

OBJECTIVE: To observe the influence of chemotherapy on hematopoietic progenitor cells (HPC) and hematopoietic microenvironment (HME). To observe whether intravenous infusion of autologous bone marrow stromal cells (ABMSC) expanded in vitro can improve the hematopoietic function. METHODS: Cultures of CFU-GM, BFU-E, CFU-E and stromal progenitor cells (CFU-F) from normal control and chemotherapeutic patients were performed. The stromal function was analyzed by the assessment of the area of flask surface covered by stromal cells (ASSC) and the time when stromal cells reach confluence (TC). The recovery of hematopoietic function in short term chemotherapy group and long term chemotherapy, with or without ABMSC infusion (1.1 - 8.7) x 10(8) post chemotherapy groups was observed. RESULTS: The yields of CFU-GM, BFU-E, CFU-E and CFU-F in long term chemotherapy group were significantly lower than that in normal group or in short term chemotherapy group. There was no significant difference among three groups in the ASSC and TC. In long term chemotherapy group, the yields of CFU-GM, CFU-E, BFU-E and CFU-F after chemotherapy with BMSC infusion were significantly higher than that without BMSC infusion. In long term chemotherapy group, the lowest value of white blood cell (WBC) and platelet after chemotherapy with BMSC infusion was significantly higher than that without BMSC infusion. The times for WBC and platelets recovered to normal were significantly shorter in BMSC group than in without BMSC. No adverse reaction was observed with ABMSC infusion. CONCLUSION: Long term chemotherapy results in severe impairment in HPC and mesenchymal progenitor cell (MPC), but has no obvious influence on the in vitro BMSC confluent layer formation. Intravenous infusion of expanded ABMSC can accelerate the recovery of hematopoiesis after chemotherapy.

Adolescent↗
PubMed2006

[Comparative study on clinical effect of postoperative arterial infusion chemotherapy and systemic chemotherapy in gastric cancer].

OBJECTIVE: To compare the clinical effect of postoperative arterial infusion chemotherapy and systemic chemotherapy in gastric cancer. METHODS: From July 1997 to July 2002, the patients undergoing radical gastric resection were randomly divided into two groups, and received systemic or arterial infusion chemotherapy three weeks after radical resection. Systemic chemotherapy was carried out for two courses with 5-fluorouracil (5-FU), pirarubicin (THP), and mitomycin (MMC) administered according to FAM program, while arterial infusion chemotherapy for four courses with the same anticancer drugs infused via the celiac artery. The outcomes were compared. RESULTS: Systemic chemotherapy was carried out in 188 cases, and arterial infusion chemotherapy in 180 cases. There were no significant differences in sex, age, tumor location, histological type, TNM stage and surgical procedure between the two groups (P > 0.05). The 1, 3, 5 year survival rates were 87.2%, 53.7% and 43.1% in systemic chemotherapy, and 93.3%, 72.2% and 53.6% in arterial infusion chemotherapy respectively (P< 0.01). CONCLUSION: The survival rate of the patients with arterial infusion chemotherapy is higher than that with systemic chemotherapy, which indicates that arterial infusion chemotherapy can remarkably improve the prognosis of the patients with gastric cancer.

Adult↗
PubMed2003

Impact of adjuvant chemotherapy and surgical staging in early-stage ovarian carcinoma: European Organisation for Research and Treatment of Cancer-Adjuvant ChemoTherapy in Ovarian Neoplasm trial.

BACKGROUND: All randomized trials of adjuvant chemotherapy for early-stage ovarian cancer have lacked the statistical power to show a difference in the effect on survival between adjuvant chemotherapy and no adjuvant chemotherapy. They have also not taken into account the adequacy of surgical staging. We performed a prospective unblinded, randomized phase III trial to test the efficacy of adjuvant chemotherapy in patients with early-stage ovarian cancer, with emphasis on the extent of surgical staging. METHODS: Between November 1990 and January 2000, 448 patients from 40 centers in nine European countries were randomly assigned to either adjuvant platinum-based chemotherapy (n = 224) or observation (n = 224) following surgery. Endpoints were overall survival and recurrence-free survival, and the analysis was on an intention-to-treat basis. The Kaplan-Meier method was used to perform time-to-event analysis, and the log-rank test was used to compare differences between treatment arms. Statistical tests were two-sided. RESULTS: After a median follow-up of 5.5 years, the difference in overall survival between the two trial arms was not statistically significant (hazard ratio [HR] = 0.69, 95% confidence interval [CI] = 0.44 to 1.08; P =.10). Recurrence-free survival, however, was statistically significantly improved in the adjuvant chemotherapy arm (HR = 0.63, 95% CI = 0.43 to 0.92; P =.02). Approximately one-third of patients (n = 151) had been optimally staged and two-thirds (n = 297) had not. Among patients in the observation arm, optimal staging was associated with a statistically significant improvement in overall and recurrence-free survival (HR = 2.31 [95% CI = 1.08 to 4.96]; P =.03 and HR = 1.82 [95% CI = 1.02 to 3.24] P =.04, respectively). No such association was observed in the chemotherapy arm. In the non-optimally staged patients, adjuvant chemotherapy was associated with statistically significant improvements in overall and recurrence-free survival (HR = 1.75 [95% CI = 1.04 to 2.95]; P =.03 and HR = 1.78 [95% CI = 1.15 to 2.77]; P =.009, respectively). In the optimally staged patients, no benefit of adjuvant chemotherapy was seen. CONCLUSION: Adjuvant chemotherapy was associated with statistically significantly improved recurrence-free survival in patients with early-stage ovarian cancer. The benefit of adjuvant chemotherapy appeared to be limited to patients with non-optimal staging, i.e., patients with more risk of unappreciated residual disease.

Adult↗
PubMed2004

Phase II study of a multidisciplinary approach with induction chemotherapy, followed by surgical resection, radiation therapy, and consolidation chemotherapy for unresectable malignant thymomas: final report.

PURPOSE: To evaluate tumor resectability after induction chemotherapy and to determine disease-free and overall survival rates of patients with locally advanced unresectable thymoma that received a multimodal treatment regimen. PATIENTS AND METHODS: Twenty-two patients (9 men, 13 women) with histologically confirmed invasive thymoma were treated with a multidisciplinary regimen consisting of three courses of induction chemotherapy, surgical resection, and radiation therapy, followed by three courses of consolidation chemotherapy. The median age was 47 years (range, 25-70). Eleven patients had stage III disease, 10 patients, stage IVA, and one patient, IVB. The most common histologic type was lymphocytic. Induction chemotherapy consisted of 500 mg/m(2) of cyclophosphamide on day 1; doxorubicin (20 mg/m(2) per day) on days 1-3 via continuous infusion (a total of 60 mg/m(2)); cisplatin (30 mg/m(2) per day) on days 1-3 (a total of 90 mg/m(2)); and prednisone (100 mg per day) on days 1-5. This cycle was repeated three times at 3-4-week intervals. Patients then underwent surgery for tumor resection and received radiotherapy. Consolidation chemotherapy given at 80% of the induction chemotherapy doses of cyclophosphamide, doxorubicin, and cisplatin and 100% of the dose of prednisone was then repeated every 3-4 weeks for a total of three courses. RESULTS: Induction chemotherapy produced major responses in 17 (77%) of the 22 patients including 3 (14%) complete responses (CR) and 14 (63%) partial responses (PR). Twenty-one patients underwent surgical exploration: 16 (76%) had complete resection and 5 (24%) had incomplete resection; one patient refused surgery. All 22 patients received radiation therapy. Nineteen of 22 patients completed the planned therapy, and all but one had completed consolidation chemotherapy at the time of analysis. With a median follow-up time of 50.3 months, 18 of the 19 patients who completed the multidisciplinary approach were disease-free. Of the 22 patients originally registered, 20 were alive at the time of analysis (one patient died of endocarditis, and one died of recurrent disease). The overall survival rate was 95% at 5 years (95% confidence interval (CI), 0.87-1.0) and 79% at 7 years (95% CI, 0.55-1.0). The progression-free survival rates were 77% at 5 years (95% CI, 0.58-1.0) and 77% at 7 years (95% CI, 0.58-1.0). The major side effect from induction and consolidation chemotherapy was myelosuppression. Nine patients experienced grade III/IV neutropenia, which included neutropenic fever in two patients, and grade III thrombocytopenia in two patients. The most common nonhematologic side effects were fatigue, nausea and vomiting, and decreased appetite. One patient experienced acute respiratory distress syndrome after surgical resection and required a prolonged hospitalization. No patients developed cardiac toxic effects, and no surgical mortality occurred. CONCLUSIONS: The use of induction chemotherapy to optimize surgical resectability of thymoma followed by radiation therapy and consolidation chemotherapy lead to good control of residual disease and high overall survival rates. We believe that this combined multidisciplinary approach prolongs lives and may cure locally advanced unresectable malignant thymomas. Future prospective multi-institutional studies are needed to further verify or define the best treatment for this patient population.

Adult↗
PubMed2004

[Cases of postoperative hepatic metastasis from gastric cancer in which hepatic arterial infusion chemotherapy with 5-FU, adriamycin and cisplatin was performed after TS-1 chemotherapy].

The prognosis of patients with hepatic metastasis of gastric cancer is poor, and standard therapies for patients are not established. Here we present two cases of hepatic metastasis from gastric cancer. In both cases, no other organ metastasis except the liver was confirmed, in which hepatic arterial infusion chemotherapy with 5-FU, adriamycin and cisplatin (FAP) were performed because TS-1 chemotherapy was not an effective chemotherapy. Case 1: An 80-year-old man had distal gastrectomy for type 2 gastric cancer (Stage II) in January 2001. A liver S8 metastatic recurrence was discovered in the 18th month post operation. After chemotherapy with TS-1 for 5 courses, a hepatic arterial infusion treatment was performed for 7 courses. The effect was PR, but the treatment was canceled because of a catheter obstruction. The patient is living without recurrence. Case 2: This case was a 73-year-old man who had distal gastrectomy for type 0 IIc gastric cancer (Stage IA) in May 1999. Multiple hepatic metastases recurred in the 32nd month post operation. After chemotherapy with TS-1 for 2 courses, a hepatic arterial infusion treatment was performed for 10 courses. The effect was CR, but a peritoneal recurrence was discovered, and a systemic chemotherapy was performed. The patient is living without recrudescence of hepatic metastasis. The hepatic arterial infusion chemotherapy with FAP was effective for gastric cancer patients with liver metastasis because TS-1 chemotherapy was not an effective chemotherapy. It is necessary to consider combined chemotherapy in addition to systemic chemotherapy.

Aged↗