ABSTRACT
BACKGROUND: Vinorelbine and cisplatin are active against squamous cell oesophageal carcinoma. The purpose of this phase II study was to evaluate the efficacy and safety of vinorelbine plus cisplatin in previously untreated patients with metastatic squamous cell oesophageal carcinoma and to estimate the progression-free survival, overall survival and quality of life (QoL) of the patient population. PATIENTS AND METHODS: Seventy-one eligible patients were entered into a study of vinorelbine 25 mg/m2 on days 1 and 8 plus cisplatin 80 mg/m2 on day 1, every 3 weeks. Degree of dysphagia relief was monitored and QoL was measured using the EORTC QLQ-C30. RESULTS: All eligible patients were assessed for response and 24 achieved a confirmed partial response (33.8%; 95% confidence interval 23-46); the median duration of response was 6.8 months, progression-free survival was 3.6 months and median survival of the whole group was 6.8 months. Toxicity was mainly related to neutropenia (grade 3/4 in 41% of patients). At cycle 2, 43% of the patients reported at least a moderate improvement in global health status/QoL and 25% experienced a large improvement. CONCLUSIONS: Vinorelbine plus cisplatin represents a well-tolerated active palliative regimen for patients with advanced squamous cell carcinoma of the oesophagus. This combination may offer a better therapeutic index than cisplatin-5-fluorouracil.
Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Carcinoma, Squamous Cell/drug therapy , Carcinoma, Squamous Cell/secondary , Cisplatin/administration & dosage , Esophageal Neoplasms/drug therapy , Esophageal Neoplasms/mortality , Palliative Care , Quality of Life , Vinblastine/analogs & derivatives , Vinblastine/administration & dosage , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Carcinoma, Squamous Cell/diagnosis , Carcinoma, Squamous Cell/mortality , Cisplatin/adverse effects , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Administration Schedule , Esophageal Neoplasms/diagnosis , Esophagectomy/methods , Female , Follow-Up Studies , Humans , Logistic Models , Male , Middle Aged , Neoplasm Staging , Risk Assessment , Statistics, Nonparametric , Survival Analysis , Treatment Outcome , Vinblastine/adverse effects , VinorelbineABSTRACT
BACKGROUND/AIMS: Although chemotherapy in advanced pancreatic cancer procures dismal results, both 5-fluorouracil and gemcitabine have shown a modest activity. We report a phase II study of gemcitabine combined with protracted 5-fluorouracil. METHODOLOGY: Gemcitabine was given at 1000 mg/m2/week intravenously, in combination with concomitant 5-fluorouracil 200 mg/m2/day as a protracted venous infusion, both 3 out of 4 weeks in patients with locally advanced or metastatic pancreatic adenocarcinoma. Twenty-nine patients were enrolled, among whom 27 were metastatic. Response rate, overall and progression-free survival were endpoints, as well as tolerance and clinical benefit. RESULTS: We observed 3 (10%) partial responses, and 12 (42%) stabilizations within which the median disease control was 5.6 months. The median progression-free and overall survivals were 2.8 and 4 months, respectively. A clinical benefit was observed in 39% of patients. Myelosuppression was the main toxicity, but no grade 4 was observed. Other toxicities were mild. CONCLUSIONS: This combination chemotherapy was well tolerated in advanced pancreatic cancer patients.
Subject(s)
Adenocarcinoma/drug therapy , Antimetabolites, Antineoplastic/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Deoxycytidine/analogs & derivatives , Fluorouracil/administration & dosage , Pancreatic Neoplasms/drug therapy , Adenocarcinoma/mortality , Adult , Aged , Antimetabolites, Antineoplastic/adverse effects , Deoxycytidine/administration & dosage , Deoxycytidine/adverse effects , Disease-Free Survival , Fluorouracil/adverse effects , Humans , Infusions, Intravenous , Injections, Intravenous , Middle Aged , Pancreatic Neoplasms/mortality , Treatment Outcome , GemcitabineABSTRACT
Twenty-two patients with metastatic cancer of the prostate were treated with ZoladexR, an LHRH analogue. In all cases plasma testosterone levels decreased to post-surgical castration values. This inhibitory effect of Zoladex on testicular steroid production had a favourable influence on the course of the malignancy, since 75 p. 100 of objective responses were obtained after 3 months of treatment. The functional symptoms were distinctly improved, and the drug was well tolerated, notably by the cardiovascular system. This immediate effectiveness seemed to last for several months, one-half of the patients still being in remission after 3 to 15 months. The beneficial effects of LHRH agonists, similar to those of pulpectomy or oestrogen therapy, are limited by the susceptibility of the tumour to hormones. In view of their effectiveness and good tolerance, LHRH agonists are useful in the management of advanced prostatic cancer, either as initial therapy or to replace a poorly tolerated oestrogen therapy. Further studies are needed to clarify their indications and the possible value of their association with anti-androgens or antimitotic drugs.
