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PubMed2006

Significance and problems in evaluations of pathological responses to neoadjuvant therapy for breast cancer.

Neoadjuvant therapy consists of systemic drug treatments before surgery for a primary cancer. Currently, several neoadjuvant therapy regimens for breast cancer that use various cytotoxic as well as endocrine-therapeutic and molecular-targeting agents have been performed in clinical practice and/or studies. In neoadjuvant therapy, pre-treatment pathological examination using materials obtained by a core needle biopsy (CNB) is necessary, and pathological diagnosis and evaluation of the biological status, such as hormone receptors and HER-2 over-expression are confirmed. In addition, CNB in the inter-phase of chemotherapy is also thought to be useful for assessment of therapeutic effects before regimens have been completed. After surgery, the therapeutic effects of neoadjuvant therapy have been mainly evaluated on the basis of pathological findings and a pathological complete response (pCR) is considered to be the main target of neoadjuvant therapy. Results of most of clinical studies including NSABP protocol B-18 and B-27 have confirmed the prognostic significance of pCR in neoadjuvant therapy and indicated the significance of pathological evaluation. However, universally accepted pathological response criteria have not been established, but evaluations of the main invasive tumor, intraductal components and regional lymph nodes are thought to be necessary. Additionally, evaluation of the effects below pCR also need examining in a study using a mild anti-cancer drug, such as hormone-therapeutic agent, and the survival outcomes of patients below pCR need to be examined and compared between each grade.

Breast Neoplasms↗
PubMed2005

Papillary serous carcinoma--a less radio-sensitive subtype of endometrial cancer.

OBJECTIVE: To explore factors that determine the response of endometrial cancer to radiation therapy. Such factors may influence treatment outcome and yield predictive information about individual patients and their tumors. METHODS: A retrospective study of the complete pathologic response (pCR) rates in the hysterectomy specimens of patients, who had undergone pre-operative radiotherapy for > or = Stage II biopsy-proven endometrial carcinoma, was performed. 62 patient records were reviewed with respect to patient characteristics, tumor stage, histological grade and subtype, radiation technique and dose, and presence or absence of pCR in the post-operative hysterectomy specimen. RESULTS: 24 of 62 specimens exhibited a pCR. The only significant factor with respect to pCR was presence of uterine papillary serous carcinoma (UPSC). None of the seven cases of UPSC displayed a pCR (P = 0.036 Fischer's exact test), despite not differing from the non-UPSC cases in any other tumor, treatment, or patient factors. No factors were found that separated non-UPSC cases with a pCR from those without. CONCLUSIONS: These data suggest an intrinsic radioresistance within UPSC, which may have implications for future treatment strategies. UPSC has documented genetic aberrations that may account for this, although its true radiosensitivity has yet to be quantitated directly. Future studies should focus on the molecular basis of its response to radiation. The reasons for the heterogeneous response of non-UPSC has yet to be elucidated and should also be investigated.

Adult↗
PubMed1995

Five-year results of neoadjuvant cisplatin, methotrexate and vinblastine chemotherapy plus radical cystectomy in locally advanced bladder cancer.

Neoadjuvant systemic cisplatin, methotrexate and vinblastine chemotherapy has been used in the treatment of 69 patients with advanced bladder cancer (stages T2-T4 N+/N0 M0). Sixty patients were evaluable for response at a median follow-up of 48 months. Preoperative resection of the tumor was purposely avoided in order to keep a marker lesion. After planned radical cystectomy, pathological complete responses (pCRs) and partial responses (pPRs) were documented in 5 (8.3%) and 29 cases (43.4%), respectively. These patients had a 5-year disease-free survival rate of 80%, which was statistically superior (p = 0.0013) to 35% for the remaining nonresponding patients. One patient (20%) with a pCR died of systemic disease after 14 months, while the remaining 4 patients (80%) are alive and free of disease after a median follow-up of 57 months. A higher percentage of pCRs and pPRs was observed in the group of patients with stage T3b-T4 tumor (pCR 11%, pPR 63%) in contrast to the patients with stage T2-T3a disease (pCR 4.5%, pPR 45.5%), even if no significant difference in the 5-year survival rate was observed between the 2 groups. Patients with a G2 tumor before chemotherapy survived longer (5-year survival rate of 78%) than those with G3 disease (5-year survival rate of 61%), but no significant difference was achieved.

Adult↗
PubMed2003

Enduring challenge in the treatment of nonsmall cell lung cancer with clinical stage IIIB: results of a trimodality approach.

BACKGROUND: Stage IIIb (T4/N3) non-small-cell lung cancer (NSCLC) is considered an inoperable disease and treatment is an enduring challenge. Surgery after induction therapy seems to improve locoregional control. We report the results of a phase II prospective trimodality trial (chemotherapy and concomitant radiotherapy plus surgery) in patients with stage IIIb NSCLC. METHODS: From November 1992 to June 2000, 39 patients (37 men and 2 women, mean age 65 years) with clinical stage IIIb (34 T4N0 to 2, 4 T2 to 3N3, 1 T4N3, excluding T4 for malignant pleural effusion) entered the study. They received intravenous infusions of cisplatin 20 mg/m(2) and 5-fluorouracil 1,000 mg/m(2) (days 1 to 4 and 25 to 28) combined with a total dose of 50.4 Gy radiotherapy delivered over 4 weeks (1.8 Gy daily). Upon clinical restaging responders underwent surgery. RESULTS: All patients were available for clinical restaging. No complete response was observed. Twenty-one patients had partial response (53.8%), 16 had stable disease (41%), and 2 had progressive disease (5.2%). Hematologic toxicity was moderate. Twenty-two patients (56.4%), 21 with partial response and 1 with stable disease, underwent surgery with no perioperative death. A radical resection was possible in 21 cases. Nine lobectomies, 3 bilobectomies, and 9 pneumonectomies were performed. Complications occurred in 5 patients (23.6%). Fourteen of the patients who underwent surgery (66.6%) showed a pathologic downstaging. A complete pathologic response was obtained in 9 cases (49%). Overall 5-year survival (Kaplan-Meier) was 23%. Resected versus non-resected patients showed a significant difference: 38% versus 5.6% (p = 0.028, log rank). CONCLUSIONS: This trimodal approach for stage IIIb NSCLC appears safe and effective. It provides good therapeutic results with acceptable morbidity in surgical cases.

Adult↗
PubMed1990

Immunohistochemical analysis of P-glycoprotein expression correlated with chemotherapy resistance in locally advanced breast cancer.

We analyzed the expression of P-glycoprotein in samples from 48 patients with locally advanced breast cancer. Tumor samples from 40 patients were obtained at mastectomy, which was performed after three cycles of induction chemotherapy consisting of doxorubicin, cyclophosphamide, vincristine, and prednisone. P-glycoprotein expression distributed focally was observed in 20 tumors by the immunoperoxidase method using the anti-p170-monoclonal antibody C219. The percentage of the tumor cell population expressing P-glycoprotein varied from less than 5% to greater than 30%; expression was observed significantly more often in tumors that showed less than partial response to the preoperative chemotherapy. Furthermore, P-glycoprotein was not expressed in eight tumor specimens obtained at the time of diagnosis, prior to chemotherapy, from patients who subsequently had pathologic complete responses. A comparative study of P-glycoprotein expression before and after chemotherapy and upon recurrence of tumor was done on a limited number of samples. No significant differences in P-glycoprotein expression were found. Therefore, it is possible that an intrinsic, rather than acquired, drug resistance may play a role in the failure of induction chemotherapy for locally advanced breast cancer.

ATP Binding Cassette Transporter, Subfamily B, Mem↗
PubMed2003

Efficacy of neoadjuvant chemoradiotherapy in resectable esophageal squamous cell carcinoma--a single institutional study.

A prospective phase II study of neoadjuvant chemoradiotherapy (CRT) for resectable esophageal squamous cell carcinoma was conducted from May 1993 to March 1996. A total of 88 patients fitted the eligibility criteria and were treated with two courses of induction chemotherapy (cisplatin 60 mg/m2/day on day 1 and 5-fluorouracil (5-FU) 1000 mg/m2/day on days 2-6) with concurrent hyperfractionated radiotherapy (48 Gy/40 fractions/4 weeks) followed by esophagectomy or definitive CRT comprising 4 cycles of cisplatin/5-FU and hyperfractionated radiotherapy (additional 12 Gy) with intracavitary brachytherapy (9 Gy). Clinical response and downstaging were achieved in 83% and 42% of the patients, respectively. With a median follow-up of 77 months, median survival time was 18 months with a 5-year survival rate of 23%. The clinical responses to CRT and surgery were independent prognostic factors for overall survival. Among the intended surgery group (n = 52), 41 (79%) patients underwent surgery and 36 had a resection with a pathologic complete response rate of 43%. When compared with a matched historical control (n = 40), there was a significant survival benefit in the multimodality arm (p = 0.04). This multimodality therapy was feasible and its efficacy was promising, especially when surgical resection was performed. The therapeutic benefit of neoadjuvant CRT remains to be assessed in large well-designed randomized trials, one of which is ongoing at our institution.

Adult↗
PubMedDate not supplied

Short-term weekly neoadjuvant chemotherapy in the treatment of locally advanced cervical cancer.

Twenty patients with locally advanced cervical cancer (FIGO stage Ib-IIa "bulky"/IIb) were treated with three courses of weekly PVB (day 1: cisplatin, 50 mg/m2; vincristin, 1 mg/m2; bleomycin, 30 IU over 24-hr) in a neoadjuvant setting. Toxicity was generally mild (no grade 3-4 toxicity was observed), and the treatment was well tolerated without reduction of programmed dose intensity. Fourteen patients (70%) experienced a clinical response and underwent surgery within 20 days after the third course of chemotherapy. Six patients (30%) with stable disease were treated with salvage radiotherapy. Two of the 14 responders experienced a pathologic complete response (14.2%); microscopic disease was detected in one patient with clinical complete response. Pelvic node metastases were found in 4/14 patients (28.5%) and microscopic parametrium involvement in 3/14 (21.4%). All 14 patients had free margins of resection. A short-term weekly platinum-based chemotherapy is highly effective, has little toxicity, and allows a prompt salvage therapy for nonresponding patients.

Adult↗
PubMed2001

Systemic therapy for hepatocellular carcinoma.

Hepatocellular carcinoma (HCC) is a common cancer worldwide. Most patients present at a stage when surgical resection is no longer possible, and face a dismal prognosis. Locoregional and intra-arterial treatments are feasible and effective only in selected patients with disease confined to the liver. For patients with extrahepatic disease or a blocked portal venous system, systemic chemotherapy is the only treatment option available. Systemic therapy has not been successful in the past, with very low response rates to single-agent chemotherapy. Recently, however, there have been reports that combination chemotherapy with currently available agents may make some initially unresectable tumors resectable and, in some cases, induce complete pathologic responses. This has led to a reconsideration of systemic therapy for HCC, the current status of which is described in this review.

Antineoplastic Agents↗
PubMed2005

Planned neck dissection after concomitant radiochemotherapy for advanced head and neck cancer.

OBJECTIVES/HYPOTHESIS: Since 1998, at our academic, multidisciplinary head and neck cancer treatment center, it has been our policy to treat appropriate patients with locoregionally advanced squamous cell carcinoma of the head and neck (SCCHN) with concomitant radiochemotherapy followed within 6 weeks by planned neck dissection(s). Our objective was to investigate the oncologic efficacy of planned neck dissection, to date, in this patient population with a focus on outcomes in the neck. STUDY DESIGN: Retrospective analysis of a cumulative patient database. METHODS: The medical records of all patients who underwent planned neck dissection(s) after concomitant radiochemotherapy for locoregionally advanced SCCHN at Beth Israel Medical Center and The Institute for Head and Neck Cancer in New York City were reviewed. For each patient, preradiochemotherapy primary and neck stage, postradiochemotherapy/preneck dissection clinical and radiographic neck status, type of neck dissection(s) performed, pathologic status of the neck dissection specimen(s), length of follow-up (after planned neck dissection), disease status at last follow-up, and site(s) of recurrence were recorded. Local, regional, and distant disease control rates were calculated by the Kaplan-Meier method. RESULTS: Fifty-one planned neck dissections were performed on 39 radiochemotherapy patients (12 patients had bilateral operations) between early 1998 and October, 2003. Thirty-two (82%) patients had N2 or greater neck disease, with 29 (74%) having T3/T4 disease at various upper aerodigestive tract primary sites. Patients received an average of 6,700 cGy and 6,000 cGy external beam radiation therapy to primary disease sites and involved cervical lymphatics respectively, concomitant with one of three platinum-based chemotherapy schedules. At a mean follow-up time of 24 (range 8-57) months for the entire study population, there has been only one neck recurrence (N2A neck). No patient with N2B (n = 11), N2C (n = 13, with majority of heminecks staged N2B), or N3 (n = 5) disease has recurred in the neck. No recurrences have occurred in the 41 heminecks (in 33 patients) where modified neck dissection (including 24 selective procedures) was performed despite the presence of residual carcinoma in 13 (32%) of these heminecks on pathologic review. Among all heminecks with residual carcinoma present (n = 18) in the neck dissection specimen, there has been only one neck recurrence. There have been no recurrences in the 26 heminecks (in 19 patients) with incomplete clinical response after radiochemotherapy despite the presence of residual carcinoma in 14 (54%) of these necks on pathologic review. The clinical and radiographic absence of residual disease after radiochemotherapy did not always predict a complete pathologic response. Surgical complications have been limited (1 chyle leak, 1 wound breakdown). CONCLUSIONS: The integration of planned neck dissection into the multidisciplinary management of patients with locoregionally advanced SCCHN is highly effective in controlling cervical metastatic disease. Modified and selective neck dissection procedures can be performed in the majority of patients, regardless of the response in the neck subsequent to concomitant radiochemotherapy. We recommend a planned neck dissection(s) in all patients staged (pretreatment) with N2 or greater neck disease and in select N1 cases.

Carcinoma, Squamous Cell↗
PubMedDate not supplied

A phase II trial testing the thermal dose parameter CEM43 degrees T90 as a predictor of response in soft tissue sarcomas treated with pre-operative thermoradiotherapy.

We prospectively evaluated whether delivering a thermal dose of > 10 cumulative equivalent minutes at 43 degrees C to >90% of the tumour sites monitored (CEM43 degrees T90) would produce a pathologic complete response (pCR) in > 75% of high-grade soft tissue sarcomas treated pre-operatively with thermoradiotherapy. The impact of thermal dose on local failure (LF), distant metastasis (DM), and toxicity was also assessed. Thirty-five patients > or = 18 years old with grade 2 or 3 soft tissue sarcomas accessible for invasive thermometry were enrolled on the protocol. All patients received megavoltage external beam radiotherapy (RT) in daily fractions of 1.8-2.0 Gy, five times a week, to a median total dose of 50 Gy and an initial hyperthermia treatment (HT) of I h duration utilizing the BSD 2000 with Sigma 60 or MAPA applicators at frequencies of 60-140 MHz. Further HT was given for patients with CEM43 degrees T90 > 0.5 after initial HT ('heatable' patients), twice a week to a maximum of 10 HT or CEM43 degrees T90 > 100. Of the 35 patients entered, 30 had heatable tumours, one of which was inevaluable for pCR or LF as the patient died of DM prior to surgery, leaving 29 evaluable patients. Of these 29 patients, 15 (52%) had a pCR (95% CI: 37-73%), significantly less than the projected rate of > or = 75% (p = 0.02). Of the 25 heatable tumours that achieved CEM43 degrees T90 > or = 10, 14 (56%) had a pCR (95% CI: 39-78%) significantly less than the projected rate (p = 0.06). Three of the 29 patients (10%) with heatable tumours had a LF, versus 1/5 unheatable tumours (p = 0.48). Fourteen of the 30 patients (47%) with heatable tumours developed DM, versus 2/5 unheatable tumours (p = 1.00). Ten of the 30 patients (33%) with heatable tumours developed treatment-induced toxicity. Thus, no correlation of thermal dose with histologic response was observed. Prospective control of CEM43 degrees T90 failed to achieve the projected pCR rate following pre-operative thermoradiotherapy for high-grade soft tissue sarcomas, despite excellent local control. Possible explanations for this outcome are discussed.

Adult↗
PubMed2004

High-dose ifosfamide with hematopoietic growth factor support in advanced bone and soft tissue sarcomas.

AIM: Ifosfamide and doxorubicin are the most effective agents in the treatment of sarcomas, although their contributions to survival are usually limited. High-dose ifosfamide can be used as a salvage treatment in patients with recurrent or advanced sarcoma. We evaluated efficacy and toxicity of high-dose ifosfamide in the patients with recurrent or advanced sarcoma in this study. METHODS: 39 patients with recurrent or advanced sarcoma were enrolled onto the study between 1996 and 2002. All patients had histological proven high grade sarcoma with measurable or evaluable disease. Ifosfamide was administered at the dose of 2 g/m(2) as continuous intravenous infusion for 24 h on day 1-9, in conjunction with the continuous infusion of mesna. Granulocyte-macrophage colony-stimulating factor or granulocyte colony-stimulating factor was given every cycle. The efficacy and toxicity of high dose ifosfamide (HDI) were evaluated clinically before subsequent cycle. The objective response was evaluated every two cycles. Histopathologic response was also evaluated in patients who underwent surgical resection. RESULTS: Male/female ratio was 24/15, with a median age of 20 (11-48) years. 9 patients had locally inoperable advanced disease and 30 patients had metastatic disease. 10 patients were chemo-naive. The total number of HDI-chemotherapy cycles was 103 (median 2 cycles (range, 1 to 7)). 2 patients refused the further treatment after the first cycle and 1 patient died due to neutropenic sepsis in the first cycle of treatment. 36 patients were available for the evaluation of treatment efficacy. Overall response rates were 53.8% and 90% in pre-treated patients and in chemo-naive patients, respectively. Median follow-up time was 43 months. 13 patients underwent total surgical tumor resection. Pathologic complete response was observed in 5 of 13 these patients who underwent surgery. Median progression-free survival (PFS) was 7 months (95%CI: 3.8-10.2). The median progression-free survival (PFS) were 3 and 12 months in patients who did not have tumor resection, and in those having complete tumor resection (p = 0.002). Median overall survival (OS) was 10 months (95%CI: 0.0-20) in all patients. Median OS times were 8 months in patients without tumor resection and 26.5 months in patients with those underwent surgical treatment (p = 0.0369). 2 patients who underwent surgery are still alive and disease-free. Major toxicity was myelosuppression. CONCLUSION: HDI seems to be feasible and effective in selected patients with advanced or recurrent sarcomas. Survival advantage of HDI is better when the total tumor resection can be done.

Adolescent↗
PubMed1995

Intraperitoneal 5-fluorouracil for pseudomyxoma peritoneii.

Pseudomyxoma peritoneii has an indolent course but a 5-year survival rate of 40-45%. The role for postoperative intraperitoneal chemotherapy is unclear. Nine patients with pseudomyxoma arising from mucinous neoplasms of the ovary and intestinal tract received a total of 89 courses of intraperitoneal 5-fluorouracil (IP5FU). Each course consisted of eight 4-h exchanges of 1 g of 5FU in 2 l of 1.5% Inpersol(R). Median follow-up after diagnosis was 30 months (range 6-74). All patients were evaluable for toxicity and response. There was one treatment-related death due to renal failure and sepsis. Three patients developed disease progression prior to scheduled second-look laparotomy. At second-look laparotomy two patients demonstrated pathologic complete responses, one had stable disease and one had progression of disease. One patient remained clinically free of progression after refusing second-look laparotomy. The projected 5-year survival by Kaplan-Meier estimate was 87% for patients treated with IP5FU compared to a 52% 5-year survival seen in a series of 11 patients treated prior to the use of IP5FU (P = 0.12). This preliminary analysis suggests that IPFU in the described schedule fails to improve survival statistically compared to previously used regimens for patients with pseudomyxoma peritoneii.

Journal Article↗
PubMed2004

Long-term results of combined-modality therapy for inflammatory breast carcinoma.

Sixty-eight patients with inflammatory breast carcinoma (IBC) received treatment in 2 prospective randomized trials of multimodality therapy for locally advanced breast cancer. The treatment plan consisted of 3 courses of neoadjuvant chemotherapy with CAF (cyclophosphamide/doxorubicin/5-fluorouracil [5-FU]) or CEF (cyclophosphamide/epirubicin/5-FU) followed by surgery and 6 adjuvant courses of CAF or CEF alternated with CMF (cyclophosphamide/methotrexate/5-FU). Radiation therapy was administered at the end of adjuvant treatment. All patients with estrogen receptor-positive tumors received tamoxifen 20 mg daily for 5 years. The response rate to induction chemotherapy was 73.6% (95% CI, 61.4%-83.5%): 4 of 68 patients (6%) exhibited a pathologic remission of primary breast tumor (persistent disease in the axilla), and 2 patients (3%) exhibited a pathologic complete response. Median follow-up was 10 years (range, 5 months to 14.7 years). Disease-free survival (DFS) rates at 5 and 10 years were 29% and 20%, respectively, and median DFS was 2.2 years (range, 3.8 months to 11.5 years). Overall survival (OS) rates at 5 and 10 years were 44% and 32%, respectively, and median OS was 4 years (range, 5 months to 14.7 years). Significant prognostic factors for DFS and OS were the number of axillary nodes and residual disease in the breast at surgery. This analysis confirmed that patients with IBC obtained significant long-term survival benefit from combined-modality therapy.

Adult↗
PubMed2004

Chemoradiation with raltitrexed (Tomudex) in preoperative treatment of stage II-III resectable rectal cancer: a phase II study.

PURPOSE: To evaluate the impact of preoperative chemoradiation with raltitrexed (Tomudex(1)) on tumor response, sphincter preservation, and toxicity in patients with locally advanced rectal cancer. METHODS AND MATERIALS: Between 1998 and 2002, 54 consecutive patients with Stage T3 or T2N+ resectable rectal carcinoma were treated with preoperative chemoradiation, i.v. bolus of raltitrexed on Days 1, 19, and 38 and concurrent 50 Gy external beam radiotherapy. Surgery was performed 6-8 weeks after the end of chemoradiation. RESULTS: No patients had Grade 4 acute toxicity. Grade 3 acute toxicity occurred in 16.6% of cases and was hematologic in 6 patients and GI in 2. The overall clinical response rate was 88.8%, with a complete response in 5.5%, partial response in 83.3%, and no change in 9.2%. No patient showed disease progression. All patients underwent surgery. Sphincter saving was obtained in 83.3% of patients. No perioperative mortality occurred, and the perioperative morbidity rate was 5.5%. Of 20 resected patients (37%) who were candidates for abdominoperineal resection at diagnosis (anorectal ring distance < or =30 mm), 13 (65%) underwent a sphincter-saving procedure. At pathologic examination, 13 (24%) of 54 patients had a complete pathologic response (pT0) and 10 (18.5%) had rare isolated residual cancer cells (pT, microscopic foci). Overall, 42.5% had major downstaging. The tumor regression grade (TRG), using Mandard's score system, was also applied and was TRG1 in 13 patients, TRG2 in 11, TRG3 in 20, and TRG4 in 10 patients; no patient had TRG5. CONCLUSION: The use of raltitrexed in a neoadjuvant chemoradiation schedule promoted high pathologic tumor downstaging and use of a sphincter-saving procedure. The low toxicity profile supports the rationale to explore raltitrexed combined with other drugs with different biologic targets.

Aged↗
PubMed2003

Histological complete response in a case of advanced gastric cancer treated by chemotherapy with S-1 plus low-dose cisplatin and radiation.

A 76-year-old male was diagnosed with stage IV (cT4, cN2, cP0, cH0, cM0) gastric carcinoma with a type 3 tumor in the cardia with lymph node metastases, determined by gastrofiberscope and abdominal computed tomography (CT). The patient was treated with chemotherapy consisting of S-1 and low-dose cisplatin (CDDP) during the first cycle (3 weeks). S-1 was orally administered at a dose of 100 mg/day (60 mg/m(2)/day) on days 1-21. CDDP was infused at a dose of 10 mg/day (6 mg/m(2)/day) on days 1-5, 8-12 and 15-19. After this cycle, the clinical response was evaluated as no change (NC). In the second cycle, radiation therapy (2 Gy/day for 5 days/week) was initiated along with the chemotherapy. The CDDP dose was decreased to 7.5 mg/day because of the grade 3 thrombocytopenia and grade 2 leukocytopenia that occurred during the first cycle. The second cycle was stopped at a total radiation dose of 48 Gy due to grade 3 thrombocytopenia and grade 2 leukocytopenia. Examination after this treatment showed remarkable reduction of tumor volume in the primary lesion and lymph nodes, which was defined as a partial response (PR). The patient then underwent total gastrectomy with D1 lymph node dissection. The postoperative course was uneventful without surgical complications. At this time, no gastric cancer cells were detected in the resected specimen, including the primary lesion and lymph nodes, confirming a pathological complete response (CR grade 3). Thus, the chemo-radiation treatment regimen described here may be a potent tool to control advanced gastric carcinoma.

Aged↗
PubMedDate not supplied

Hepatic arterial infusion of oxaliplatin and L-folinic acid-modulated 5-fluorouracil for colorectal cancer liver metastases.

BACKGROUND: Despite the progress made in the treatment of metastatic colorectal cancer (CRC), the results of second-line chemotherapy remain poor. PATIENTS AND METHODS: The feasibility of hepatic arterial infusion (HAI) of oxaliplatin (100 mg/m2 over 6 h) followed by l-folinic acid (L-FA) (400 mg over 2 h i.v.)-modulated continuous HAI of 5-Fluorouracil (5-FU) (60 mg/kg over 42 h; q2w) as second-line chemotherapy for metastatic CRC limited to the liver was investigated. RESULTS: A median of 9 treatment cycles were administered (range 4-14). Treatment-limiting toxicity consisted of: abdominal pain (3 patients), elevated liver enzymes accompanied by fatigue (3), elevated bilirubin (2), neutropenia (2), thrombocytopenia (3) and hypersensitivity to oxaliplatin (1). Normalization for >4 weeks of the carcinoembryonic antigen (CEA) level was documented in 3 patients and a decline of >50% for >4 weeks in 5 patients. A confirmed partial response (PR) was documented in 5, stable disease (SD) in 1 and progressive disease (PD) in 3 patients. In the latter 3 patients, lung metastases developed while a PR was observed in the liver metastases. A pathological complete response (CR) was documented in 2 patients. The median time to progression was 7.2 months (95% CI 1.3-13) and the median overall survival 18.3 months (95% CI 16.3-20.3). CONCLUSION: HAI of oxaliplatin plus CI5-FU/LV is feasible and merits further evaluation.

Adult↗
PubMed2002

Predictors of local-regional recurrence after neoadjuvant chemotherapy and mastectomy without radiation.

PURPOSE: To define clinical and pathologic predictors of local-regional recurrence (LRR) for patients treated with neoadjuvant chemotherapy and mastectomy without radiation. PATIENTS AND METHODS: We analyzed the outcome of the 150 breast cancer cases treated on prospective institutional trials with neoadjuvant chemotherapy and mastectomy without postmastectomy radiation. Clinical stage at diagnosis was I in 1%, II in 43%, IIIA in 23%, IIIB in 25%, and IV in 7%. No patient had inflammatory breast cancer. RESULTS: The median follow-up period of surviving patients was 4.1 years. The 5- and 10-year actuarial rates of LRR were both 27%. Pretreatment factors that positively correlated with LRR were increasing T stage (P <.0001) and increasing combined clinical stage (P <.0001). Pathologic and treatment factors that positively correlated with LRR were size of the residual primary tumor (P =.0048), increasing number of involved lymph nodes (P <.0001), and no use of tamoxifen (P =.0013). The LRR rate for the 18 patients with a pathologic complete response of both the primary tumor and lymph nodes (pCR) was 19% (95% confidence interval, 6% to 48%). In a forward stepwise Cox logistic regression analysis, clinical stage IIIB or greater (hazard ratio of 4.5, P <.001), pathologic involvement of four or more lymph nodes (hazard ratio of 2.7, P =.008), and no use of tamoxifen (hazard ratio of 3.9, P =.027) independently predicted for LRR. CONCLUSION: Advanced disease at presentation and positive lymph nodes after chemotherapy predict for clinically significant rates of LRR. Achievement of pCR does not preclude the need for postmastectomy radiation if warranted by the pretreatment stage of the disease.

Adult↗
PubMed2003

Gemcitabine and cisplatin as induction chemotherapy for patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma: an Italian Lung Cancer Project Observational Study.

BACKGROUND: The objective of this trial was to evaluate the activity and safety of one of the newer platinum-based doublets as a neoadjuvant regimen in patients with unresectable Stage IIIA-bulky N2 and Stage IIIB nonsmall cell lung carcinoma (NSCLC). METHODS: From June 1996 to April 2000, 129 consecutive patients with locally advanced NSCLC were treated with gemcitabine, 1000 mg/m(2) on Days 1 and 8 and cisplatin, 70 mg/m(2) on Day 2 (GC) of a 21-day treatment cycle, for 4 cycles, as part of a combined-modality approach. RESULTS: After induction chemotherapy, 80 patients (62%; 95% confidence interval, 53.6-70.4%) achieved a partial response, 43 patients (33%) had stable disease, and 6 patients (5%) had disease progression during chemotherapy. Forty patients (31%), were considered resectable and underwent thoracotomy. Complete resectability was obtained in 38 patients (29%), with 2% of patients achieving a pathologic complete response. After surgery, 9 patients with Mountain Classification Stage IIIA NSCLC and 9 patients with Stage IIIB NSCLC received definitive adjuvant radiotherapy. Forty-six of 52 patients with Stage IIIB disease and 24 of 37 patients with Stage IIIA disease who were not considered suitable for surgery received definitive radiotherapy. The median time to disease progression was 11.4 months, the median survival was 19.4 months (range, 1.2-55.2 + months), and the 1-year survival rate was 74%. The lungs (33%) and the brain (21%) were the main sites of recurrence. Major toxicity was comprised of Grade 3-4 thrombocytopenia, which occurred in 34 patients (27%). CONCLUSIONS: GC administered according to a 3-week schedule was a highly active and safe regimen in patients with primary, unresectable, locally advanced NSCLC.

Adult↗