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PubMed2005

American Joint Committee on Cancer tumor-node-metastasis stage after neoadjuvant chemotherapy and breast cancer outcome.

BACKGROUND: Response to neoadjuvant chemotherapy is used as an intermediate endpoint for breast cancer relapse and survival. Most breast cancer response classification systems use pathologic complete response, either alone or in conjunction with clinical assessments, to categorize response. We examined the ability of the revised 2003 American Joint Committee on Cancer (AJCC) tumor-node-metastasis (TNM) staging system, which considers both the number of involved axillary lymph nodes and the extent of tumor in the breast to predict patient survival after neoadjuvant chemotherapy for breast cancer. METHODS: We assessed the pathologic stage of residual tumor in 132 patients with nonmetastatic breast cancer after they had undergone neoadjuvant chemotherapy and examined the association between AJCC TNM stage and subsequent distant disease-free survival and overall survival. All statistical tests were two-sided. RESULTS: At a median follow-up of 5 years, pathologic stage in the surgical specimens after neoadjuvant chemotherapy using the revised AJCC system was strongly associated with both distant disease-free survival and overall survival. A higher pathologic stage of residual tumor after neoadjuvant chemotherapy was associated with a statistically significant lower rate of distant disease-free survival (stage 0: 95%, stage I: 84%, stage II: 72%, and stage III: 47%; Ptrend < .001). The 5-year distant disease-free survival for patients with residual stage IIIC tumors was only 18% (95% CI = 0% to 36%). CONCLUSION: Classification of residual tumor in the breast and axillary surgical specimens after neoadjuvant chemotherapy using the revised AJCC TNM system is useful for predicting distant relapse and survival.

Adult↗
PubMed1996

The use of mammography in breast preservation in locally advanced breast cancer.

PURPOSE: As the feasibility of breast preservation in locally advanced breast cancer is currently under evaluation, little information is available correlating mammographic changes to chemotherapy with local outcome. To evaluate the role of mammography in selecting candidates with locally advanced breast cancer for conservative local therapy, we analyzed mammographic changes in the breast to induction chemotherapy and correlated the radiologic appearance with pathologic outcome. METHODS AND MATERIALS: From 1985 through 1993, 91 patients with Stage III breast cancer were enrolled on a multimodality clinical trial using chemohormonal therapy followed by local treatment and maintenance therapy. Induction therapy consisted of cyclophosphamide, doxorubicin, methotrexate,and 5-fluorouracil with hormonal synchronization using tamoxifen and conjugated estrogens. After nine cycles, surgical biopsies of the breast were performed. Through 1988, clinical examination alone directed the site for postinduction biopsy; for patients treated after 1988, mammography, in addition to physical examination, determined the biopsy location. Local treatment was determined by biopsy result. Patients with a pathologic complete response received radiation only to the breast adn regional nodes, while those with pathologically proven residual disease underwent mastectomy and postoperative radiotherapy. Nine additional cycles of maintenance chemotherapy were administered. RESULTS: Fifty-five of 91 patients (58%) obtained a clinical complete response (CR) to induction chemotherapy. Twenty-eight of the 53 women with a clinical CR had both pre- and postinduction mammograms. Of these 28 women, 9 obtained a pathologic CR and 19 obtained a pathologic partial response (PR). Fifty-five percent of the pathologic complete responders had resolution of mammographic abnormalities on the postinduction mammograms. Sixty-eight percent (13) of the pathologic partial responders had abnormal mammographic findings. The positive predictive value for residual cancer using physical examination was 92%, while the negative predictive value was only 36%. Among patients with a clinical complete response, the positive and negative predictive values for residual cancer using postinduction mammography were 79% and 56%, respectively. Limitations of mammography included uncertain significance of residual microcalcifications and residual masses on postinduction chemotherapy mammograms. CONCLUSIONS: Although mammography improved the accuracy of noninvasive evaluations in patients with a clinical complete response, pathologic assessment was still required to determine appropriate local therapy. More sensitive imaging modalities or modifications of film-screen mammography may improve noninvasive detection of residual disease following induction chemotherapy.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1999

Preoperative chemoradiation with cisplatin and 5-fluorouracil for extraperitoneal T3 rectal cancer: acute toxicity, tumor response, sphincter preservation.

PURPOSE: To evaluate the impact of preoperative external radiation therapy intensified by systemic chemotherapy including bolus cisplatin (c-DDP) and 4-day infusional 5-fluorouracil (PLAFUR-4) on tumor response and sphincter preservation in patients with extraperitoneal T3 rectal cancer with acceptable toxicity, and to compare the results to our previous experience with bolus mitomycin c (MMC) and 4-day infusion 5-FU (FUMIR). METHODS AND MATERIALS: Between October 1995 and March 1998, 40 consecutive patients with resectable extraperitoneal adenocarcinoma of the rectum were treated with preoperative chemoradiation: slow infusion i.v. c-DDP, 60 mg/m2, day 1 and 29 plus 24-h continuous infusion i.v. 5-fluorouracil (5-FU) 1000 mg/m2, days 1-4 and 29-32, and concurrent external beam radiotherapy (45 Gy whole pelvis followed by 5.4 Gy boost). All but 3 patients had T3 disease. Surgery was performed 6-8 weeks after the end of chemoradiation. RESULTS: No patient had Grade 4 acute toxicity. Grade 3 hematological toxicity was observed only in 2 (5%) patients. No patient had major gastrointestinal, skin, or urological acute toxicity. All patients had radical surgery. There was no perioperative mortality; perioperative morbidity rate was 12%. Overall, 23% (9 of 40) of patients had a complete pathological response and 10% (4 of 40) of patients had rare isolated residual cancer cells (Tmic). Comparing the stage at the diagnostic workup with the pathological stage, tumor downstaging was observed in 27 (68%) patients; nodal status downstaging was detected in 24 (60%) patients. Thirty-four (85%) patients had a sphincter-saving surgical procedure. In 4 of 10 (40%) patients who were definitive candidates for an abdominoperineal resection (APR), the sphincter was preserved, as it was in 13 of 13 (100%) probable candidates. Lengthening of the distance between the anorectal ring and the lower pole of the tumor > or =20 mm was observed in 9 (23%) patients. None of the patients had soilage after the sphincter-saving procedure. In our previous experience with FUMIR the complete pathological response was 9%, the sphincter-saving surgical procedure was performed in 66% cases, and the Grade 3+ toxicity was observed in 13% of patients. CONCLUSIONS: The addition of c-DDP to 5-FU (PLAFUR-4) in a neoadjuvant radiochemotherapy schedule improved the pathological response rate in comparison with our previous experience. Toxicity was low indeed, thus we commenced another study adding one more day of 5-FU infusion (PLAFUR-5) to further improve our results.

Adult↗
PubMed1995

Serum half-life of CA 125 during early chemotherapy as an independent prognostic variable for patients with advanced epithelial ovarian cancer: results of a multicentric Italian study.

This retrospective multicentric study assessed the prognostic value of the serum CA 125 assay and the common clinicopathological variables in 225 patients with advanced epithelial ovarian cancer. All of these patients had serum CA 125 > or = 35 U/ml before the first cycle of chemotherapy and had had serial antigen determinations during early chemotherapy. By univariate analysis pathological complete response rate was significantly related to stage, size of residual disease after first surgery, serum CA 125 before the first cycle and before the third cycle of chemotherapy, and serum CA 125 half-life. Multiple logistic regression showed that residual disease (P = 0.002), serum CA 125 half-life (P = 0.004), serum CA 125 before the third cycle (P = 0.004), and serum CA 125 before the first cycle (P = 0.03) retained a significant value in predicting second-look findings. By log-rank test survival was significantly related to stage, residual disease, tumor grade, serum CA 125 before the third cycle, and serum CA 125 half-life. Cox proportional hazard model showed that residual disease (P = 0.0001), serum CA 125 half-life (P = 0.007), and tumor grade (P = 0.01) retained a significant value in predicting survival. In conclusion, serum CA 125 half-life during early chemotherapy was an independent prognostic factor for both the achievement of a pathological complete response and the survival of patients with advanced epithelial ovarian cancer.

Adult↗
PubMed2003

The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27.

PURPOSE: The National Surgical Adjuvant Breast and Bowel Project Protocol B-27 was designed to determine the effect of adding docetaxel after four cycles of preoperative doxorubicin and cyclophosphamide (AC) on clinical and pathological response rates and on disease-free and overall survival of women with operable breast cancer. PATIENTS AND METHODS: Women (N = 2,411) with operable primary breast cancer were randomly assigned to receive either four cycles of preoperative AC followed by surgery (group I), or four cycles of AC followed by four cycles of docetaxel, followed by surgery (group II), or four cycles of AC followed by surgery and then four cycles of docetaxel (group III). Clinical and pathologic tumor responses to preoperative therapy were assessed. RESULTS: Mean tumor size (4.5 cm) and other key characteristics were evenly balanced among the three treatment arms. Grade 4 toxicity was observed in 10.3% of 2,400 patients during AC treatment, and in 23.4% of 1584 patients during docetaxel treatment. Compared to preoperative AC alone, preoperative AC followed by docetaxel increased the clinical complete response rate (40.1% v 63.6%; P <.001), the overall clinical response rate (85.5% v 90.7%; P <.001), the pathologic complete response rate (13.7% v 26.1%; P <.001), and the proportion of patients with negative nodes (50.8% v 58.2%; P <.001). Pathologic primary breast tumor response was a significant predictor of pathologic nodal status (P <.001). CONCLUSION: The addition of four cycles of preoperative docetaxel after four cycles of preoperative AC significantly increased clinical and pathologic response rates for operable breast cancer.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed1989

Cisplatin, 5-fluorouracil, and high-dose oral leucovorin for advanced head and neck cancer.

Both cisplatin and leucovorin may increase the activity of 5-fluorouracil (5-FU) by increasing the intracellular concentration of reduced folates. Therefore, a Phase I study was conducted in patients with recurrent or metastatic head and neck cancer in which high doses of oral leucovorin were added to the combination of cisplatin and 5-FU. Patients received intravenous cisplatin 100 mg/m2 on day 1, followed by a continuous intravenous infusion of 5-FU at 600 mg/m2/day for 5 days. Leucovorin 50 mg/m2 orally was administered from the start of the cisplatin infusion and then every 6 hours throughout the 5-FU infusion. The dose of 5-FU was increased to 800 mg/m2/day and 1 g/m2/day according to observed toxicity. In a second phase of the study, the dose of leucovorin was increased to 50 mg/m2 orally every 4 hours. Twenty-five patients were registered: 23 had recurrent head and neck cancer after extensive treatment; two had newly diagnosed metastatic disease. The maximum tolerated dose of 5-FU was 800 mg/m2/day with leucovorin administered every 6 hours. Toxicities at that level included mild-to-moderate myelosuppression. Mucositis in the previously irradiated field prevented the further increase of the 5-FU dose to 1 g/m2/day. Identical toxicities were observed when administering 5-FU at 800 mg/m2/day with 50 mg/m2 of leucovorin every 4 hours. Eighteen patients were evaluated for response: one had a pathologic complete response; nine had a partial response (including four who had previously received cisplatin and 5-FU as induction chemotherapy). Eight patients did not respond. The median survival for all 25 patients was 6.5 months. It was concluded that the combination of cisplatin, 5-FU, and leucovorin is active in the treatment of recurrent head and neck cancer. The maximum tolerated dose of 5-FU in previously treated patients is 800 mg/m2/day, with mucositis being the dose-limiting toxicity. Further investigation of this regimen as neoadjuvant chemotherapy in previously untreated patients with locally advanced head and neck cancer is in progress.

Adult↗
PubMed2006

Analysis of efficacy and toxicity of chemotherapy with cisplatin, 5-fluorouracil, methotrexate and leucovorin (PFML) and radiotherapy in the treatment of locally advanced squamous cell carcinoma of the head and neck.

PURPOSE: The aim of this study was to evaluate the efficacy and toxicity of concurrent chemoradiotherapy using cisplatin (CDDP), 5-fluorouracil (5-FU), methotrexate (MTX) and leucovorin (LV) (PFML) in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). METHODS: Seventy-seven patients with previously untreated stages III-IV SCCHN were included in this trial. Patients received two cycles of chemotherapy repeated every 4 weeks. The chemotherapy regimen consisted CDDP (60 mg/m2, day 4), 5-FU (600 mg/m2 given over 24 h for 5 days, days 1-5), MTX (30 mg/m2, day 1) and LV (20 mg/m2, days 1-5). Radiation was targeted to begin on the starting day of chemotherapy, day 1. The total radiation dose to the primary site and neck lymph nodes was 70.0 Gy. When grade>or=3 toxicities were observed frequently, radiotherapy and/or chemotherapy were delayed or reduced. RESULTS: The main toxicities were mucositis (grade>or=3, 39%), leukocytopenia (grade>or=3, 34%) and neutropenia (grade>or=3, 30%). The overall clinical response rate and the pathological complete response (CR) were 94% (72/77) and 71% (55/77). The primary site CR and neck lymph node CR were 79% (61/77) and 85% (44/52), and 3-year survival rate was 73%. CONCLUSIONS: This concurrent chemoradiotherapy with PFML was safe and well tolerated. The high CR rate justifies further evaluation of this chemoradiotherapy modality in locally advanced SCCHN patients.

Adult↗
PubMed1992

High-dose platinum chemotherapy in advanced ovarian cancer: a phase II study.

From September 1986 to November 1988, 38 patients with previously untreated ovarian cancer, FIGO stages III and IV, were allocated to a study testing the efficacy of high-dose platinum delivered as combined carboplatin and cisplatin. The regimen was as follows: Day 1, 250-350 mg/m2 carboplatin and 500 mg/m2 cyclophosphamide, Day 15, 100 mg/m2 cisplatin. Overall clinical response was 60%, and complete pathologic response, verified at second-look laparotomy, was 24%. Median survival was 17 months and 3-year survival 27%. The results are similar to those obtained by a standard dose of cisplatin, cyclophosphamide, and doxorubicin. Myelotoxicity was dose limiting. After receiving four cycles, 44% of patients had grade 3 or 4 leucopenia and 65% had grade 3 or 4 thrombopenia. Despite this, dose intensity of combined cisplatin and carboplatin was between 30 and 45 mg/m2/week, expressed as cisplatin by assuming that 1 mg cisplatin equals 4 mg of carboplatin. A correlation between dose intensity and response was not found. In conclusion the study showed that the regimen is feasible, but very myelotoxic. The results were not superior to those obtained by combination chemotherapy using standard doses of cisplatin.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Neoadjuvant chemotherapy followed by vaginal radical trachelectomy in bulky stage IB1 cervical cancer: case report.

BACKGROUND: We present 3 young women with bulky stage IB1 cervical cancer treated with neoadjuvant chemotherapy followed by laparoscopic pelvic node dissection and vaginal radical trachelectomy. CASES: In the last year, we have treated 3 young women with large cervical lesions who wished to preserve fertility with induction chemotherapy followed by fertility-sparing surgery. They all had lesions measuring 3 to 4 cm and felt to be too big to safely undergo a radical trachelectomy. Three cycles of platinum-based combination chemotherapy were given and were well tolerated. The 3 patients had a significant clinical response to chemotherapy. A complete pathological response was confirmed by the absence of residual invasive cancer in the three trachelectomy specimens. There has been no recurrence so far and no pregnancy yet. CONCLUSION: Neoadjuvant chemotherapy followed by a fertility-sparing surgery may become a valuable option for young women with bulky stage IB1 cervical cancer who wish to preserve their fertility potential.

Adult↗
PubMed1994

Phase II trial for intraperitoneal cisplatin plus intravenous sodium thiosulphate in advanced ovarian carcinoma patients with minimal residual disease after cisplatin-based chemotherapy--a phase II study of the EORTC Gynaecological Cancer Cooperative Group.

On the basis of its efficacy against ovarian carcinoma and its safe peritoneal administration, cisplatin administered by the intraperitoneal route was studied in a phase II multicentric trial. 34 patients with good performance status and residual disease less than 1 cm were treated with a 90 mg/m2 dose (60 mg/m2 at first cycle), administered in the abdominal cavity every 3 weeks for at least four cycles. In case of haematological or renal toxicity, intravenous sodium thiosulphate was perfused simultaneously with intraperitoneal cisplatin with protective intent. 25 patients were evaluable for response: 3 patients had pathological complete response and 1 patient had a microscopic disease (16% response rate in evaluable patients). Systemic toxicity was mild, and sodium thiosulphate clearly protected against leucopenia (6 patients) and renal toxicity (8 patients). Local side-effects were evaluable in 34 patients with 2 cases of infectious peritonitis, 1 of wound infection and 2 of haemorrhage. Of the 147 evaluable chemotherapy cycles, nine resulted in partial and one in total inflow obstruction, for which 4 patients needed surgical procedures for catheter-related complications, and 1 patient died of acute abdominal complications after such a procedure. We conclude that 90 mg/m2 intraperitoneal cisplatin has activity in pretreated patients with minimal residual disease, and that thiosulphate protects against haematological and renal toxicities. Only a randomised study can demonstrate a true benefit, which will have to be balanced with the toxicity of intraperitoneal drug administration.

Aged↗
PubMed1999

Phase II study of a combination of low-dose cisplatin with 13-cis-retinoic acid and interferon-alpha in patients with advanced head and neck squamous cell carcinoma.

Preclinical and clinical data have suggested antitumor efficacy in squamous cell carcinoma (SCC) of interferon (IFN)-alpha and 13-cis-retinoic acid (13-c-RA) as single agent with greater activity in combination. Cisplatin was added to potentiate activity. Twenty-three patients with pretreated advanced or metastatic head and neck squamous cell carcinoma were given a combination of IFN-alpha (6 x 10(6) U/day, 84 days s.c.), 13-c-RA (1 mg/kg/day, 84 days) and cisplatin (40 mg/kg/day, day 1, 28 and 56). Seventeen patients had discontinuation of treatment and three patients received overall treatment without dose reduction. Hematological toxicity was more frequent; only three patients experiencing grade 3 or higher extra-hematological toxicity. Four out of 14 evaluable patients were in response, with one in complete pathological response. Median duration of response was 6 months with a 9 month median survival. Association of IFN-alpha, 13-c-RA and cisplatin induces modest but definite antitumor activity with moderate and manageable toxicity. Further studies of different combination modality therapy with chemotherapy and differentiating agents need to be performed in less pretreated patients.

Aged↗
PubMed1988

Cisplatin, fluorouracil, and high-dose leucovorin for recurrent or metastatic head and neck cancer.

We added high-dose oral leucovorin to the combination of cisplatin and fluorouracil (5-FU) to assess the efficacy of this regimen in the treatment of patients with head and neck cancer. Cisplatin, 100 mg/m2, was followed by a 5-FU continuous infusion at 600 mg/m2/d for five days. Leucovorin, 50 mg/m2, was administered at the start of cisplatin and every six hours throughout the duration of the 5-FU infusion. The dose of 5-FU was escalated to 800 mg/m2 and 1,000 mg/m2 according to observed toxicity. In a second phase of the study, the dose of leucovorin was escalated to 50 mg/m2 every four hours. A total of 25 patients were registered: 23 had recurrent disease after extensive prior treatment; and two had newly diagnosed metastatic disease. The maximally tolerated dose of 5-FU was 800 mg/m2/d with leucovorin administered every six hours. Toxicities at that level included mild to moderate myelosuppression and dose-limiting mucositis in the previously irradiated field. Identical toxicities were observed when administering 800 mg/m2/d of 5-FU with leucovorin every four hours. Eighteen patients were evaluated for response: one had a pathologic complete response; nine had a partial response (including four who received prior cisplatin and 5-FU as induction chemotherapy); and eight patients failed to respond. The mean peak and trough plasma leucovorin concentrations were 2.61 (+/- 1.07) mumol/L and 2.46 (+/- 0.95) mumol/L with administration of the drug every six hours, and 2.75 (+/- 2.15) mumol/L and 2.52 (+/- 1.48) mumol/L with administration every four hours. We conclude that the combination of cisplatin, 5-FU, and leucovorin has activity in the treatment of recurrent head and neck cancer. The maximally tolerated dose of 5-FU in this study was 800 mg/m2/d, with mucositis in previously irradiated sites being dose-limiting. Plasma leucovorin concentrations exceeding 1 mumol/L are achieved following oral administration of this drug.

Adult↗
PubMedDate not supplied

Feasibility of breast conservation surgery in locally advanced breast cancer downstaged by neoadjuvant chemotherapy: a study in mastectomy specimens using simulation lumpectomy.

BACKGROUND: The response of locally advanced breast cancer (LABC) to neoadjuvant chemotherapy (NACT) offers these patients previously treated by mastectomy, the chance for breast conservation. AIM: This study aims to assess the feasibility of lumpectomy in patients with LABC treated by NACT, with residual tumor < or =5 cm. SETTINGS, DESIGN: Single group prospective study from August 2001 to June 2003 in a teaching hospital. MATERIALS AND METHODS: Thirty patients with LABC whose tumors reduced with NACT to 5 cm were included. Simulation lumpectomy was performed on the mastectomy specimens to achieve 1 to 2 cm clearance from tumor and hence margin negativity. Multiple sections of the inked margin were studied. STATISTICAL ANALYSIS: Margin positivity was correlated with patient factors. Chi square test and Fisher's exact test used as appropriate. P value 0.05 was considered significant. RESULTS AND CONCLUSIONS: After three cycles of NACT, 4 patients (13%) had complete clinical response including 2 with complete pathological response. Twenty-two (73%) showed partial response and 4, no response. Fourteen out of thirty (47%) had tumor involvement of margins. Tumors with post-chemotherapy size> 4 cm were margin positive in 10/13 (77%). Tumors with post-chemotherapy size>3 cm were margin positive in 13/24 (54%). Tumors with post-chemotherapy size 3 cm were margin negative in 5/6 (83%). Pre-chemotherapy tumor size and post-chemotherapy tumor size were significantly associated with margin positivity (P=0.003). Tumors in the subareolar location had significantly higher incidence of residual tumor in the nipple areola complex. (P=0.04). Margin positivity of lumpectomy on downstaged tumors can be reduced by removing the nipple areola complex in subareolar tumors and by limiting breast conservation to tumors with post-chemotherapy size < or =3 cm.

Adult↗
PubMed1996

Neoadjuvant combined microwave induced local hyperthermia and topical chemotherapy versus chemotherapy alone for superficial bladder cancer.

PURPOSE: We evaluated the effectiveness of local bladder hyperthermia and intravesical chemotherapy compared to intravesical chemotherapy alone in the treatment of superficial transitional cell carcinoma. MATERIALS AND METHODS: A new system designed to deliver simultaneously local bladder hyperthermia and intravesical chemotherapy has been developed at our institute. The system consists of a computerized 915 MHz. microwave source that directly heats the bladder walls (within a temperature range of 42.5 to 45.5C) using a transurethral catheter. From February 1989 to December 1993, 52 patients 44 to 81 years old (mean age 64.3) with superficial stages Ta to T1, grades 1 to 3 transitional cell carcinoma of the bladder were selected for neoadjuvant intracavitary treatment. Tumors were left intact as marker lesions. Of the patients 29 were randomly assigned to receive combined neoadjuvant intravesical chemotherapy and local hyperthermia (group 1), while 23 received intravesical chemotherapy alone (group 2). The treatment protocol included multiple sessions performed on an outpatient basis. Mitomycin C (40 mg. in 50 cc distilled water) was used for intravesical chemotherapy in both groups. All patients underwent transurethral resection of residual tumors and of all suspicious areas 7 to 10 days after completion of treatment. Only a complete response was considered for statistical analysis. RESULTS: A pathological complete response was documented in 19 cases (66%) in group 1 and 5 (22%) in group 2 (chi-square p< 0.01). CONCLUSIONS: According to these preliminary data, microwave induced hyperthermia combined with local intravesical chemotherapy seems to be a feasible, safe and promising approach for neoadjuvant and minimally invasive treatment of superficial bladder cancer.

Adult↗
PubMed2002

[Chemoradiotherapy using platinum analogs/5-FU for advanced esophageal cancer].

We evaluated the efficacy of concurrent chemoradiotherapy (CRT) using cisplatin/nedaplatin and 5-FU for advanced esophageal cancer. Thirteen patients with locally advanced esophageal cancer (T4 cases) and 3 with recurrence of esophageal cancer were treated with radiotherapy (40-70 Gy) and 5-FU combined with cisplatin/nedaplatin concurrently. T4 patients who obtained down-staging by CRT also underwent esophagectomy. A complete response was obtained in one case, partial response in 8 cases, and no change in 7 cases. The overall response rate was 56.3%. A pathological complete response was obtained in one case in which curative resection was performed after CRT. Bone marrow suppression was observed in 68.8% and grade 3 and 4 bone marrow suppression was observed in 43.8%. Concurrent CRT using cisplatin/nedaplatin and 5-FU for advanced esophageal cancer has a high response rate and patients obtaining down-staging by CRT as a neoadjuvant therapy have a chance for long survival after curative resection in locally advanced cases.

Adult↗
PubMed2006

Is trimodality approach better then bimodality in stage IIIA, N2 positive non-small cell lung cancer?

BACKGROUND: Neoadjuvant treatment followed by surgery is currently being investigated for locally advanced non-small cell lung cancer (NSCLC). This study reports efficacy, toxicity and feasibility of neoadjuvant chemotherapy with concurrent radiotherapy (CCRT) in stage IIIA, N2 positive NSCLC. METHODS: From March 2001 to February 2004, 52 patients with histologically confirmed stage IIIA, N2 positive NSCLC were registered. Patients received preoperative CCRT that consisted of weekly paclitaxel plus platinum chemotherapy and concurrent radiotherapy followed by surgery. RESULTS: Overall response rate was 76.9% (95% CI, 64-88%). The major grade 3-4 toxicities were radiation esophagitis (15.4%) and neutropenia (11.5%), and treatment-related mortality rate was 1.9%. Forty-two of 52 patients (80.8%) subsequently underwent surgical resection and 35 of 52 patients (67.3%) underwent complete resection. Among them, pathological complete response was obtained in 4.8%. Pathological downstaging rate to N0-1 and stage 0-II at surgery were 69.0% and 66.7%, respectively. The perioperative major morbidity rate was 23.8% and perioperative mortality was 2.4%. At a median follow-up of 33.9 months (range: 16.4-49.9), the median progression-free survival and overall survival were 16.5 months (95% CI, 6.2-26.8) and 25.6 months (95% CI, 14.6-36.6), respectively. Multivariate analyses identified that patients achieved mediastinal nodal clearance (downstage to pathological N0 or N1) after CCRT (p=0.02) and age at diagnosis<60 years (p=0.01) showed significantly improved survival. CONCLUSION: Neoadjuvant CCRT showed a high overall response rate with tolerable toxicity profile. Downstaging after CCRT may increase the rate of complete tumor resection and result in survival benefit in stage IIIA, N2 positive NSCLC patients.

Adult↗
PubMed2000

Paclitaxel, cisplatin, and epirubicin first-line chemotherapy in stage III and IV ovarian carcinoma: long-term results of a phase II study.

BACKGROUND: The combination of paclitaxel with cisplatin or carboplatin has become the preferred chemotherapy regimen in the treatment of epithelial ovarian carcinoma. Anthracyclines also have activity in this disease. We conducted a Phase II study by using the combination of paclitaxel, cisplatin, and epirubicin for the treatment of advanced ovarian carcinoma. METHODS: Forty consecutive patients with optimally (n = 7) or suboptimally (n = 33) debulked advanced ovarian carcinoma (International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV) were treated with paclitaxel, 135 mg/m(2), as a 3-hour intravenous infusion, cisplatin 75 mg/m(2) intravenously (i.v.), and epirubicin 50 mg/m(2) i.v. every 3 weeks on an outpatient basis. Granulocyte-colony stimulating factor was administered at a dose of 5 microg/kg/day on Days 5-9. RESULTS: Among 28 patients with measurable disease, 24 (86%%) achieved an objective response including 19 complete and 5 partial responses. Among 18 patients who underwent reassessment laparotomy, pathologic complete response was confirmed in 9 patients. At a minimum follow-up of 40 months, the median overall survival had not been reached whereas the median time to progression for all patients was 18.7 months. The median remission duration for women with measurable disease who responded to treatment was 14 months. The treatment was well tolerated without toxic deaths; the most common toxicity was Grade 3/4 neutropenia that occurred in 30% of patients. Significant neuropathy (Grade 2 or higher) developed in only 8% of patients. CONCLUSIONS: The combination of paclitaxel, cisplatin, and epirubicin is a well tolerated outpatient regimen with significant activity in the treatment of advanced epithelial ovarian carcinoma.

Adult↗
PubMed1993

High-dose cisplatin and cyclophosphamide with glutathione in the treatment of advanced ovarian cancer.

BACKGROUND: On the basis of preliminary results achieved with a high-dose cisplatin regimen including glutathione as chemoprotector, the efficacy and toxicity of the new regimen was further evaluated in a larger series of patients with advanced ovarian cancer (stage III and IV). PATIENTS AND METHODS: The study included patients with bulky or extensive residual disease after primary laparotomy or with bulky inoperable tumor masses. A total of 79 patients were treated with up to five courses of high-dose cisplatin (40 mg/m2 daily in normal saline, for four days) plus glutathione (2500 mg as a short-term infusion before cisplatin), together with cyclophosphamide (600 mg/m2 as an i.v. bolus on day 4). A standard i.v. hydration consisting of a total of 2000 ml of fluids without diuretics was employed. RESULTS: All eligible patients, who received a total of 345 courses, were assessed for response and toxicity and 52 received the planned five courses of the protocol. Forty-five patients (57%) achieved complete clinical responses and 20 (25%) had partial remissions for an overall response rate of 82%. The response rate was critically dependent on tumor size before chemotherapy. Thirty-eight of 45 patients who had complete clinical responses underwent second-look laparotomy, and 29 had pathological complete responses (37%). Seventeen of these 29 patients subsequently relapsed (median disease-free interval, 12 months; range, 6-45). With a median follow-up time of 44 months, the median survival for the 79 analyzed cases was 40 months. The toxicity of the regimen was moderate. Nausea/vomiting was the most severe acute toxicity. Myelotoxicity was acceptable, with severe leukopenia and thrombocytopenia (grade 4) occurring in 8% and 3% of patients, respectively. Nephrotoxicity was minimal with a transient increase (to < 2 mg/dL) in serum creatinine in only 6 patients (8%). Peripheral neurotoxicity and ototoxicity were the most significant long-term toxicities. The severity of these side effects (grade 3 WHO neurotoxicity occurred in only 4% of patients) was apparently less than has been reported with other high-dose cisplatin regimens. Neurotoxicity required discontinuation of therapy in three patients after four courses. Most affected patients had complete or partial recovery of symptoms with time. DISCUSSION: The efficacy and tolerability of the regimen confirm the feasibility of this new approach including glutathione in order to increase cisplatin dose intensity. The superiority of this regimen over standard induction therapy should be confirmed in randomized trials.

Adult↗