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PubMed1998

Surgical considerations in preoperative chemotherapy of breast cancer.

Primary systemic chemotherapy for breast cancer was initially directed at downsizing tumors to make them acceptable candidates for breast-conserving surgery. Later trials used this approach in the hope of improving disease-free survival and overall survival. Results from NSABP protocol B-18 indicate significant initial tumor response and downstaging of lymph nodes in 30% of patients. Patients with small tumors were more likely to experience complete clinical response and complete pathologic response. Patients with larger tumors whose surgeons would have chosen mastectomy often responded with tumor decrease to a size at which lumpectomy was considered feasible. The local recurrence rate in these patients was higher than in those patients selected for lumpectomy primarily. Nevertheless, even with a higher rate of ipsilateral breast tumor recurrence, approximately 90% of women older than 50 years and 83% of younger women had successful breast-conserving surgery. There was no difference in disease-free survival or overall survival between preoperative and postoperative chemotherapy groups. The response of patients to initial chemotherapy can be a useful tool in exploring the biology of breast cancer.

Breast Neoplasms↗
PubMed1989

High-dose platinum consisting of combined carboplatin and cisplatin in previously untreated ovarian cancer patients with residual disease.

A phase II trial of carboplatin, 300 mg/m2 day 1, and cisplatin, 50 mg/m2 days 2 and 3 every 4 weeks for six cycles, was performed in 42 previously untreated patients with residual disease after primary laparotomy. Overall, 79% of patients had primary residual tumor larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 37 evaluable patients was 62%, and in PCRs was 22%. Of the responding patients, 78% had primary residual tumor larger than 2 cm. The toxicity was cumulative but manageable, with thrombocytopenia being the main reason for dose reduction. Dose-limiting nephrotoxicity and neurotoxicity occurred in 22% and 7% of the patients, respectively. Combined high-dose platinum as a "single agent" appears to be as active as combination chemotherapy containing cisplatin, and the treatment is feasible. Further clinical trials of this combination alone or combined with other drugs are warranted.

Adult↗
PubMed1990

Combined high-dose carboplatin and cisplatin, and ifosfamide in previously untreated ovarian cancer patients with residual disease.

Carboplatin 200 mg/m2 day 1, cisplatin 50 mg/m2 days 2 and 3, ifosfamide 1,500 mg/m2 days 1 to 3, and mesna 900 mg/m2 days 1 to 3 every 4 weeks for six cycles were given to 37 previously untreated ovarian cancer patients with residual disease after the primary laparotomy. The median observation time was 17+ months (range, 9+ to 24+ months). Of all the patients, 81% had primary residual disease larger than 2 cm. The overall pathologic response rate (pathologic complete response [PCR] plus partial response [PPR]) in 36 assessable patients was 58%, PCR was 42%. Of the PCR patients, 53% had primary residual tumor larger than 5 cm. The substantial hematologic toxicity was manageable, but also the main reason for dose modifications. During treatment, 92% and 100% of the patients developed WBC and platelet nadir values corresponding to World Health Organization (WHO) grades 3 to 4. Dose-limiting encephalopathy, nephro- and neurotoxicity each occurred in 6% of the patients. The high PCR rate warrants further investigations of combined high-dose platinum and ifosfamide.

Adult↗
PubMed1994

Pilot study of preoperative chemotherapy with cisplatin, vinblastine, and dacarbazine in patients with local-regional recurrence of melanoma.

BACKGROUND: Because the prognosis of patients with local-regional recurrence of melanoma treated with surgery alone usually is poor, the authors conducted a study designed to determine the efficacy of preoperative chemotherapy using cisplatin, vinblastine, and dacarbazine (CVD) in this patient population. METHODS: Eligibility included biopsy-proven, measurable, and potentially resectable local-regional disease in the form of lymph node metastases, satellite/in-transit metastases and/or local recurrence. CVD consisted of cisplatin, 20 mg/m2 intravenously (IV) on days 2-5; vinblastine, 1.6 mg/m2 IV on days 1-5; and dacarbazine, 800 mg/m2 IV on day 1 only, repeated every 3 weeks. Patients usually received two to three courses of CVD and then underwent surgery. Postoperatively, patients who responded continued CVD for a maximum of 8 courses; nonresponders received no further therapy. RESULTS: Of 52 consecutive patients (40 with lymph node involvement and 12 with skin metastases), 5 (10%) achieved a pathologic complete response and 20 (38%) achieved a partial response, for an overall response rate of 48% (95% confidence interval, 34-62). Of the five patients who achieved a pathologic complete response, three had attained a clinical complete response and one a partial response, and one had stable disease after initial chemotherapy. At a median follow-up of 54 months (range, 32-69 months), 38% of the patients remained disease free. CONCLUSION: Preoperative chemotherapy with CVD has significant activity in local-regional recurrences of melanoma, resulting in pathologic complete response in 10% of the patients. Because its impact on survival remains unclear, this treatment strategy should currently remain investigational. Preoperative chemotherapy, however, could be offered to certain patients with bulky, borderline resectable, regional disease for whom cytoreduction may make surgery easier or less mutilating.

Adult↗
PubMed1998

[Long term results of esophageal epidermoid cancers in complete remission after preoperative chemo-radiotherapy].

INTRODUCTION: Improvements of the results of combined chemoradiotherapy (CRT) in esophageal cancer has led several groups to adopt a non surgical attitude specially in case of complete response (endoscopy +/- biopsy). Few information are available about the follow-up of these patients. We studied long-term results of 35 patients who underwent resection after complete response to preoperative chemoradiotherapy. PATIENTS AND METHODS: 161 patients with resecable carcinoma of the thoracic esophagus have received the same protocol of CRT (cisplatin 80 mg/m2, radiation therapy split course: 37.5 Gy) all patients were followed every for 4 months (no lost of view). RESULTS: Complete response (endoscopy and biopsy) was obtained for 35 patients (21.7%), 19 of them (54%) had pathologic complete response (PCR) (no tumor in the specimen), 16 have microscopic foci of residual tumor (46%). The overall 5-year survival rate was 49.8% for the whole group (median survival 64 months), 70% for the group without tumor in the specimen, 48% for the group with microscopic foci of residual tumor (NS). CONCLUSIONS: One half of the complete response (endoscopy + biopsy) have not a pathologic complete response (microscopic foci of residual tumor in the specimen). The 49.8% of five year survival suggests a benefit from esophagectomy for complete response after combined chemoradiotherapy.

Adult↗
PubMed1998

A phase II trial of preoperative mitomycin, cisplatin and 5-fluorouracil in adenocarcinoma of the oesophagus.

The effect of neoadjuvant chemotherapy in patients with apparently operable adenocarcinoma of the oesophagus has been investigated. Two courses of mitomycin, cisplatin and 5-fluorouracil (MCF) were given, followed by a radiological evaluation of response. Twenty-two of 25 patients completed both courses. Two showed a complete response and 12 a partial response. There was a pathological complete response of the primary tumour in only one patient (although there was residual secondary tumour in a local lymph node). The main toxicity was myelosuppression, with 9/22 patients having the second chemotherapy course delayed. There were three sudden deaths, one due to a pulmonary embolus and two due to complications of infections. Twenty-one patients underwent surgical exploration; there were 18 resections. Although the radiological response rate of MCF (14/25; 56%; 95% CI 37-75) appeared promising, there were no pathological complete responders. Further Phase II trials are needed to identify more efficacious agents and regimens that will yield a pathological response rate of at least 10%, before proceeding to randomized trials of neoadjuvant chemotherapy for adenocarcinoma of the oesophagus.

Adenocarcinoma↗
PubMed1997

Induction therapy for esophageal cancer with paclitaxel and hyperfractionated radiotherapy: a phase I and II study.

OBJECTIVE: Induction chemoradiotherapy followed by surgery may improve survival rates among patients with esophageal carcinoma. We designed a novel intense induction regimen with paclitaxel and high-dose hyperfractionated radiotherapy to maximize complete response rates. METHODS: Forty patients with esophageal cancer were treated in a phase I and II trial of induction chemotherapy (cisplatin, 5-fluorouracil, and paclitaxel) at three dosage levels (75, 125, and 100 mg/m2) and concurrent hyperfractionated radiotherapy (45 Gy to the mediastinum, 58.5 Gy to the tumor). The mean age was 62 years, and 32 patients (80%) had adenocarcinoma. Twenty-eight of 40 (70%) patients had locally advanced tumors (T3, or stage IIB or greater). RESULTS: The average hospitalization for induction treatment was 17 days. Toxicity was substantial, with esophagitis necessitating nutritional support the most common complication. The maximum tolerated dose of paclitaxel was 100 mg/m2. Two patients died during induction treatment. Thirty-six patients (90%) underwent resection. The median length of stay was 10 days, and two patients died after the operation. Fourteen of 36 patients (39%) had a pathologic complete response. Patients who received all prescribed chemotherapy had a higher pathologic complete response rate (50%) than did patients who required dose reduction (17%; p = 0.076). The 2-year survival rate was 61% (95% CI 35% to 86%) with a median follow-up of 11.9 months. CONCLUSIONS: Paclitaxel at a dose of 100 mg/m2 appears to have acceptable toxicity. The high pathologic complete response rate in this regimen is encouraging, but it is associated with substantial toxicity. The toxicity of this regimen is not acceptable and will require substantial reduction in the radiation component. Survival data are too short-term to confirm enhanced survival.

Adenocarcinoma↗
PubMed1994

Systemic chemotherapy for muscle invasive bladder cancer.

A total of 60 patients with muscle invasive transitional cell carcinoma of the bladder were entered into the nonrandomized study. The 1st group consisted of 30 patients treated by M-VAC neo-adjuvant chemotherapy followed by radical cystectomy when a residual tumor had been detected by biopsy made after the treatment. The overall clinical response was 70%. Fifteen (50%) out of 30 patients achieved clinical complete response (cCR). Objective pathologic response was attained in 6 (66.7%) of 9 evaluable patients who underwent radical cystectomy, pathologic complete response (pCR) was observed in two (22.2%) patients. Ten (33.3%) patients are still alive at a median follow-up of 22+ months. There were three (10%) drug-related deaths. The 2nd group consisted of 30 patients treated by CMV (with carboplatin) neo-adjuvant chemotherapy followed by radical pathologic response was attained in 9 (47.4%) of 19 evaluable patients, with pCR in 6 (31.6%) patients. Twenty four (80%) patients are still alive at a median follow-up of 13+ months. There was one (3.3%) drug-related death. The authors recommend immediate radical cystectomy following neo-adjuvant chemotherapy in all patients if their total status it allows.

Adult↗
PubMedDate not supplied

Intensive chemoradiation followed by esophagectomy for squamous cell and adenocarcinoma of the esophagus.

PURPOSE: To determine the pathologic complete response rate, toxicity, and survival of patients with resectable squamous cell or adenocarcinoma of the esophagus treated with a 30-day preoperative chemoradiation regimen and surgical resection. PATIENTS AND METHODS: Fifty patients (16 squamous, 33 adeno, one undifferentiated) who had carcinoma of the esophagus (limited to the primary tumor and regional or celiac nodes) were treated with cisplatin 26 mg/m2/day continuous infusion days 1 through 5 and 26 through 30, 5-fluorouracil (5-FU) 300 mg/m2/day continuous infusion days 1 through 30, and radiation 44 Gy, 2 Gy/fx in 22 daily fractions, days 1 through 30, followed by esophagectomy. RESULTS: Forty-seven patients underwent esophagectomy (94% operability rate), and 45 had total gross removal of disease and negative margins of resection (90% resectability rate). Nineteen patients (40%) had a pathologic complete response (CR). Forty (80%) received 100% of the planned cisplatin dose, 29 (58%) received 100% of the planned 5-FU dose, and 40 (80%) received > or = 80% of the planned 5-FU dose. Forty-five (90%) received the planned 44-Gy radiation dose. Grade 3 or 4 neutropenia occurred in 60% of patients. The incidence of febrile neutropenia was 34%. There was one septic death during chemoradiation and no operative deaths. Weight loss requiring nutritional support occurred in 50% of patients, secondary to anorexia, dysphagia, and/or esophagitis. The survival of all registered patients at a median follow-up of 43 months was 2-year survival 58%, median 31.3 months. Survival analysis by histology showed no difference between the two histologic types (squamous vs adenocarcinoma). However, survival by pathologic response was significantly different: pathologic CR, 19 patients, 2-year survival 78%, median survival 58 months; and pathology positive, 28 patients, 2-year survival 46%, median survival 22.4 months. A Cox proportional hazards model and logistic regression analysis demonstrated a significant survival advantage for pathologic CRs and stage I disease versus higher-stage disease and a correlation between chemotherapy dose received and pathologic staging. DISCUSSION: This 30-day chemoradiation regimen followed by surgery resulted in a high pathologic complete response rate, 40%, and apparent survival advantage for this group. The median survival rate of 31.3 months and 2-year survival rate of 58% suggest that this regimen may improve survival over surgical treatment alone. Randomized trials with large accrual and statistical power are necessary to confirm our results and to determine optimal treatment.

Adenocarcinoma↗
PubMed1997

Paclitaxel, carboplatin, and long-term continuous 5-fluorouracil infusion in the treatment of upper aerodigestive malignancies: preliminary results of phase II trial.

We evaluated the efficacy and toxicity of a novel chemotherapy regimen that included paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ), carboplatin, and long-term, continuous-infusion 5-fluorouracil in the treatment of cancers of the upper aerodigestive tract. In the preoperative treatment of patients with localized esophageal cancer, we administered this regimen concurrently with radiation therapy. Thirty-eight patients with biopsy-proven cancers of the head and neck or esophagus entered this trial between January 1996 and November 1996. Patients with head and neck cancers considered curable with local treatment modalities were excluded. All patients received the following chemotherapy regimen: paclitaxel 200 mg/m2 via 1-hour intravenous infusion on days 1 and 21, carboplatin at an area under the concentration-time curve of 6.0 intravenously on days 1 and 21, and 5-fluorouracil 225 mg/m2/d via continuous infusion on days 1 to 42. Patients with localized esophageal cancer also received radiation therapy beginning on day 1 (1.8 Gy/d; total dose, 45 Gy). Patients were re-evaluated at week 6; responding patients received a repeat course of treatment, except for those with localized esophageal cancer, who underwent resection at week 10. Twenty-five of 29 evaluable patients had major responses to treatment. Four of five patients with locally advanced head and neck cancer had complete clinical responses, while eight of 11 patients with metastatic disease responded. All 13 evaluable patients with localized esophageal cancer underwent resection, and nine (69%) had a pathologic complete response. Toxicity was moderate, with brief grade 3/4 leukopenia occurring in 19 patients (66%). Esophagitis occurred in five of 13 patients receiving concurrent chemotherapy and radiation therapy, but was reversible and generally occurred during the last week of radiation therapy. Other grade 3/4 toxicity was uncommon. This novel regimen of paclitaxel, carboplatin, and long-term 5-fluorouracil infusion is feasible and highly active in patients with cancers of the upper aerodigestive tract. It can be used concurrently with radiation therapy before resection for localized esophageal cancer. The high overall response rates, and particularly the high pathologic complete response rates in resected patients with esophageal cancer, are encouraging and warrant further evaluation of this regimen.

Adult↗
PubMed1998

Induction chemoradiotherapy for advanced stage III non-small cell lung cancer: long-term follow-up in 42 patients.

This multi-institutional phase II study was designed to assess the feasibility, efficacy, toxicity, and long-term survival of induction chemoradiotherapy followed by surgery in previously untreated patients with advanced stage III non-small cell lung cancer. Chemotherapy regimen included cisplatin 20 mg/m2 on days 1-5 and 29-33, and VP-16 40 mg/m2 on days 1-5 and 29-33. Radiotherapy (50 Gy in 25 fractions) began on day 1. Clinically downstaged patients underwent thoracotomy 3-5 weeks after the completion of radiotherapy. Forty-two eligible patients (ten stage IIIA and 32 IIIB) were followed for a median period of 64 months. The response rate was 81%, and 20 patients had a clinically good response. Twenty-one patients underwent thoracotomy. Nineteen patients had complete resections and there were seven pathologic complete responses. There were four treatment related deaths (all stage IIIBs). There were significant survival differences between stage IIIA versus IIIB patients (P = 0.028; median survivals, 24.9 vs. 11.1 months; 5-year survival rates, 20% vs. 8.3%), and patients that achieved pathologic complete response (CR) versus those that did not (P = 0.045; median survivals 30.1 vs. 11.1 months; 5-year survival rates, 28.6% vs. 8.3%). Although the induction chemoradiotherapy employed in this study was not appropriate for stage IIIB patients, it proved feasible in stage IIIA patients in whom it resulted in good 5-year survival rates. It also provided good survival rates in patients achieving pathologic CR.

Adult↗
PubMed1990

Prognostic factors in stage IV ovarian carcinoma treated with platinum-based regimens.

Eight factors were analyzed for prognostic significance in univariate analyses in a series of 76 women with stage IV ovarian carcinoma treated with combination chemotherapies including cisplatin or carboplatin. The clinical objective and pathologic complete response rates were 51.2% and 27.3%, respectively. Median overall survival and progression-free survival were 15 and 7 months, respectively. No variables reached statistical significance. Trends toward better survival were noted for grades 1 and 2 for the adriamycin-containing regimen. Using progression-free survival as an end point, significant prognostic factors included complete clinical or pathologic response. Our data confirm that the standard approach is unlikely to modify the clinical outcome of stage IV ovarian cancer. New treatment modalities including high-dose-intensity regimens and neo-adjuvant chemotherapy delivered before surgery could improve clinical results. Moreover, biologic characterization of ovarian tumors may provide information to design specifically targeted treatment.

Adult↗
PubMed1994

Phase II trial of intraperitoneal carboplatin in ovarian carcinoma patients with macroscopic residual disease at second-look laparotomy. A multicentre study of the French Fédération Nationale des Centres de Lutte Contre le Cancer.

BACKGROUND: Because of its antitumour activity and its pharmacological advantage when administered by the intraperitoneal route, carboplatin was studied in a phase II multicentric trial. The aim of the study was to determine the response rate and the toxicity of carboplatin administered intraperitoneally and to determine if pathological complete response could be attained in women with macroscopic residual ovarian cancer at second-look laparotomy after intravenous cisplatin chemotherapy. PATIENTS AND METHODS: Twenty-nine patients with macroscopical residual disease after intravenous cisplatin-based chemotherapy at second-look laparotomy, were treated at that time with 300 mg/m2 of carboplatin administered in the abdominal cavity every four weeks for six cycles. In instances of negative findings at physical and CT scan examination, laparotomy evaluation was performed and the catheter was removed. The dose of carboplatin was increased or decreased according to hematological toxicity. RESULTS: Efficacy is evaluable in 25 pts: 2 pts had pathological complete responses and 1 pt had microscopic disease (12% response rate of evaluable patients). Toxicity is evaluable for 135 cycles in 29 patients. No grade 4 hematological toxicity was observed, 2 pts had grade 3 leukopenia and 3 pts had grade 3 thrombocytopenia; grade 3 vomiting was observed in 11% of cycles. No peritoneal complication was observed; catheter dysfunction occurred after the first cycle in one patient who refused a surgical procedure to remove the catheter and to pursue treatment. CONCLUSION: Intraperitoneal carboplatin demonstrates efficacy in patients with macroscopical residual disease at second-look laparotomy after first-line cisplatin chemotherapy. The recommended dose for further studies is 300 mg/m2 administered every 4 weeks. A low response rate does not favour a randomised study.

Adult↗
PubMed1992

Therapy of patients with metastatic breast cancer with 5-fluorouracil, leucovorin and carboplatin.

Thirty-four women with metastatic breast cancer were treated at the National Cancer Institute of the National Institutes of Health, with a regimen of leucovorin (L), 500 mg/m2 i.v. over 30 min, followed in 1 h by 5-fluorouracil (5-FU), 375 mg/m2 i.v. bolus on days 1-5, and carboplatin (CBDCA), 50-100 mg/m2 i.v. bolus on days 2-4, every 28 days. All patients had received previous combination chemotherapy with at least one regimen (29 patients with 5-FU-containing regimens). CBDCA, 100 mg/m2 on days 2-4, resulted in grade 4 neutropenia in 10 out of 11 patients associated with sepsis in all 10 patients. CBDCA, 75 mg/m2 (seven patients) and 50 mg/m2 (15 patients), resulted in grade 4 neutropenia in six and eight patients, and neutropenic sepsis in five and two cases, respectively. Grade 4 thrombocytopenia occurred in 10, five and two patients receiving 100, 75 and 50 mg/m2 of CBDCA, respectively. Other toxicities included grade 3/4 mucositis in 18 patients and grade 3/4 diarrhea in 10 patients. Twenty nine patients were evaluable for response, with one pathologic complete response (3%), two partial responses (6%), 18 stable disease (53%) and eight (24%) progressive disease. Sites of response included bone, viscera and soft tissue. The median time from entry on study to progression, for responders, was 15 months. When platinum-DNA adduct formation in peripheral white blood cells was analyzed in 27 patients at 24 h after drug administration, a significant correlation between adduct level and CBDCA cumulative dose was found.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1997

Weekly cisplatin given for 2 months versus cisplatin plus cyclophosphamide given for 5 months after cytoreductive surgery for advanced ovarian cancer.

PURPOSE: To compare the efficacy of a treatment with cisplatin plus cyclophosphamide given for 5 months and a short treatment with cisplatin alone in advanced ovarian cancer, we conducted a multicenter randomized clinical trial. PATIENTS AND METHODS: Eligibility criteria were as follows: first diagnosis of histologically confirmed invasive epithelial ovarian cancer of International Federation of Gynecology and Obstetric (FIGO) stage III-IV, age younger than 75 years, and Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2. Within 28 days of cytoreductive surgery, eligible women were randomly assigned treatment with weekly cisplatin 50 mg/m2 for nine courses or cisplatin 75 mg/m2 plus cyclophosphamide 750 mg/m2 every 21 days for six courses. RESULTS: A total of 607 women were entered onto the study. There was no difference in the response to treatment. Pathologic complete response (CR) was documented in 63 of the weekly cisplatin cases and 70 of the cisplatin plus cyclophosphamide group (chi 1(2) = 1.43; P = .23). The median follow-up time was 3 years. There were 151 and 148 deaths in the weekly cisplatin and cyclophosphamide plus cisplatin arms, respectively. Survival curves were similar in the two groups, with a 3-year percent survival estimate of 44.1 (SE = 3.4) in the weekly cisplatin and 44.6 (SE = 3.4) in the cisplatin plus cyclophosphamide group (log-rank test chi 1(2) = 0.004; P = .96). CONCLUSION: This study found that 2-month monochemotherapy treatment with cisplatin was as effective as 5-month polychemotherapy including cisplatin at a similar doses but different dose-intensity plus cyclophosphamide.

Adult↗
PubMed1991

Alpha 2b interferon (IFN) by intraperitoneal administration via temporary catheter in ovarian cancer. Preliminary data.

Thirty-nine patients with epithelial ovarian cancer admitted to the Division of Medical Oncology of the Medical School II of Naples were given 159 courses of alpha 2b interferon (30 Mil./sqm IU) intraperitoneally from October 1986 to November 1989. IFN was generally administered every three weeks, but six patients received the drug weekly at the same dose, for an additional period. In 15 patients IFN was added to standard systemic chemotherapy as first line treatment; the remaining patients, all pretreated (22 with minimal and 2 with no residual disease), received an intraperitoneal multidrug treatment combining IFN, cisplatin and mitoxantrone. Peritoneal access was achieved through a temporarily implanted 18 gauge catheter and the drug was instilled in a large fluid volume (2,000 ml) to ensure wide spread and uniform distribution. IFN was well tolerated: only one patient had to discontinue treatment because of severe fatigue. No major complication related to catheter implantation or function occurred. 3/15 untreated and 11/20 pretreated patients, evaluable for response, achieved a pathological complete response (pCR). In view of IFN's lack of significant toxicity and the safety and tolerability of a temporary small gauge catheter for peritoneal access, intraperitoneal chemotherapy including IFN should be useful in ovarian cancer patients with minimal or absent disease after first-line systemic treatment.

Adult↗
PubMed1987

The treatment of advanced stage ovarian carcinoma with a combination of chemotherapy, radiotherapy, and radiosensitizer: report of a pilot study from the National Cancer Institute.

Twenty-eight patients with Stage III or IV ovarian carcinoma were treated with combined chemotherapy-radiotherapy employing a unique protocol. Four cycles of cyclophosphamide and hexamethylmelamine alternated with four cycles of concurrent cisplatin, whole abdominal radiotherapy, and intraperitoneal misonidazole. The entire treatment program lasted six months. Clinical complete responses were seen in 50% of the patients with an overall response rate of 61%. Pathologic complete response (PCR) confirmed at second look surgery occurred in 18% of the group (5 patients). Median survival of the entire group was 15.2 months with all PCR's alive NED. This outcome was no different than our previous experience with combination chemotherapy alone. Toxicities seen included leukopenia, thrombocytopenia, nausea, vomiting, and weight loss. However, these side effects were manageable. Two non-tumor deaths occurred. This study demonstrates the feasibility of combining drug and radiation therapy concurrently in the treatment of ovarian cancer; further research is needed to explore different sequencing and dose levels that could improve the outcome.

Adult↗
PubMed1995

Feasibility of five courses of pre-operative chemotherapy in patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction.

The purpose of this study was to examine the feasibility of administering all chemotherapy pre-operatively to patients with resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. 32 patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction were studied in a stepwise fashion in which combination chemotherapy with cisplatin, high-dose arabinoside and 5-fluorouracil was administered. In the first part, 15 patients were to receive three chemotherapy courses pre-operatively and two chemotherapy courses postoperatively. In the second part, the next 15 patients were to receive all five chemotherapy courses pre-operatively, provided there was an objective response after three courses. Endoscopic ultrasonography was also performed, when feasible, prior to chemotherapy and surgery, and in some patients sequentially between chemotherapy courses. All of the 14 assessable patients in the first group tolerated all three courses of pre-operative chemotherapy, and 86% of patients in this group completed all protocol chemotherapy. In the second group, 9 of 18 (50%) assessable patients tolerated all five courses of preoperative chemotherapy, and 100% of patients in this group received all protocol chemotherapy. The median number of chemotherapy courses for the entire group (32 patients) was five (range one to five). Forty-one per cent (13/32) of patients had a major response to chemotherapy. Sixty-nine per cent (or 76% of 29 patients taken to surgery) had a curative resection. One patient had a pathological complete response. The median survival time of 32 patients was 17 months (range 2-36+ months). 14 patients (37%) remain alive at a median follow-up time of 26+ months. There was a correlation between endoscopic ultrasonographic tumour and nodal stage and pathological tumour and nodal stages in 16 patients. The tumour stage correlation was higher (75%) than the nodal stage correlation (62%). Our data suggest that it is feasible to administer five courses of cisplatin-based chemotherapy to patients with potentially resectable adenocarcinoma of the oesophagus or gastrooesophageal junction. More effective chemotherapy regimens that might result in higher pathological complete response rates and acceptable toxic effects are needed.

Adenocarcinoma↗