ABSTRACT
We conducted a multiinstitutional phase II clinical trial to determine the toxicity, response, and survival rate of concurrent 72-h continuous infusion of etoposide and cisplatin in patients with metastatic breast cancer. A total of 26 women were enrolled, 4 of whom received no prior chemotherapy for metastatic disease. All patients were evaluated for toxicity, response, and survival employing the National Cancer Institute (NCI) Common Toxicity Criteria and the Eastern Cooperative Oncology Group (ECOG) response criteria. A total of 84 cycles of therapy were administered, median 3 (range 1 to 6). Severe grade 3 and grade 4 neutropenia occurred in 22 cycles (26%), and there were only 11 episodes (11%) of similar grade thrombocytopenia. Nausea and vomiting were seen in one third of cycles. A single patient (4%) had a complete remission, and seven patients (27%) had partial remissions for an overall objective response rate of 31% (95% confidence interval, 13 to 49%). Three of four patients (75%) without prior therapy for metastatic disease had objective responses. Median survival was 7 months. This combination regimen is active in extensively treated patients with metastatic breast cancer. It is responsible to further investigate the role of etoposide-cisplatin combination chemotherapy as firstline therapy for patients with metastatic breast cancer.
Subject(s)
Antineoplastic Agents, Phytogenic/administration & dosage , Antineoplastic Agents/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/secondary , Cisplatin/administration & dosage , Etoposide/administration & dosage , Adult , Aged , Antineoplastic Agents/adverse effects , Antineoplastic Agents, Phytogenic/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Cisplatin/adverse effects , Confidence Intervals , Etoposide/adverse effects , Female , Humans , Infusions, Intravenous , Middle Aged , Nausea/chemically induced , Neutropenia/chemically induced , Remission Induction , Survival Rate , Thrombocytopenia/chemically induced , Vomiting/chemically inducedABSTRACT
We conducted a preliminary phase II clinical trial to determine the toxicity, response, and survival rate of 72-hour continuous infusion etoposide administered to patients with AIDS-related Kaposi sarcoma. Nine patients with biopsy proven and measurable disease AIDS-related Kaposi sarcoma were treated with a continuous infusion of etoposide at a dose of 100 mg/m2 per day for 3 days every 3 weeks. All patients were evaluated for toxicity, response, and survival employing the NCI Common Toxicity Criteria, and both the Eastern Cooperative Oncology Group (ECOG) and AIDS Clinical Trials Group (ACTG) response criteria. All patients enrolled had at least two on-study poor risk factors by ACTG staging criteria. A total of 17 cycles of therapy were administered. Thirty-five percent of cycles were associated with grade 3 or greater leukopenia. Infectious complications were common, and there was one toxic death. Two partial responses (22%) by ACTG criteria were observed (95% confidence interval, 0% to 51%). In the absence of objective responses using more strict solid tumor response criteria and toxicity encountered we believe further evaluation of a 72-hour continuous infusion schedule of etoposide in patients with advanced AIDS and poor risk Kaposi's sarcoma is not warranted.
Subject(s)
Acquired Immunodeficiency Syndrome/complications , Antineoplastic Agents, Phytogenic/administration & dosage , Etoposide/administration & dosage , Sarcoma, Kaposi/drug therapy , Sarcoma, Kaposi/virology , Adult , Antineoplastic Agents, Phytogenic/adverse effects , Drug Administration Schedule , Etoposide/adverse effects , Humans , Infusions, Intravenous , Male , Neoplasm Staging , Sarcoma, Kaposi/pathologyABSTRACT
Nine patients with stage IIIB non-small cell lung cancer were entered into a phase II trial designed to determine the feasibility of giving a combination of paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) plus cisplatin concurrent with thoracic radiation. Paclitaxel was given as a 24-hour infusion (135 mg/m2) followed by cisplatin (75 mg/m2) every 4 weeks, for a total of four cycles. Thoracic radiation was given concurrently with the first two cycles of chemotherapy, for a total dose of 64.8 Gy over 6 weeks. Neutropenia and esophagitis were the most common toxicities, with 66% of patients experiencing grade 3 or 4 neutropenia and 55% experiencing grade 3 or 4 esophagitis. Grade 3 pulmonary toxicity developed in 33% of patients. All patients were able to receive the full dose of radiation, although half of the patients required some modification of the chemotherapy regimen. There was one complete response and four partial responses, yielding a 56% overall response rate. This study demonstrates that it is feasible to treat patients with stage IIIB non-small cell lung cancer with paclitaxel/cisplatin plus concurrent thoracic radiation, with a degree of toxicity comparable with that associated with a degree of toxicity comparable with that associated with other concurrent combined-modality regimens for this disease.
