Treatment with adriamycin (ADM) and bleomycin (BLEO) alone and in combination has been evaluated in 56 patients with a variety of advanced stage gynecologic cancers. ADM has a high degree of antitumor activity against uterine sarcomas (leiomyosarcoma and stromal sarcoma) and some of the unusual ovarian cancers including ovarian teratoma. ADM was also active and gave clinically worthwhile responses against squamous cell carcinoma of the cervix and vagina. Occasional objective remissions were seen in patients with epithelial ovarian adenocarcinomas. The combination of ADM plus BLEO appeared to show no enhancement of the effect achieved by ADM alone. There were no objective responses in patients with squamous cell carcinoma of the cervix treated with BLEO alone. The usual toxic manifestations of ADM and BLEO were observed, and there appeared to be no potentiation of the toxicity of each agent when used in combination. It is concluded that ADM is a valuable chemotherapeutic agent for certain gynecologic cancers which are usually refractory to other chemotherapeutic agents. Further investigation of its use alone and in combination with other drugs is indicated.
e18859 Background: To report the outcomes of therapeutic regimens being evaluated for patients with stage IV non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy in clinical trial and real-world settings. Methods: A systematic literature review was undertaken to identify clinical trials and real-world studies evaluating treatments for stage IV NSCLC after progression with platinum-based chemotherapy. Studies were included in the review if they were published between September 2017 and September 2021, in English, and included an outcome of interest. The outcomes of interest were overall response rate, progression-free survival, overall survival, the incidence of grade 3-4 adverse events, and discontinuation due to adverse events. Results: A total of 23 studies were identified, comprising of 17 clinical trials and six real-world studies. The total sample size ranged from 12 to 1,253 patients in clinical trials and 11 to 383 patients in real-world studies. A total of 28 and six treatment regimens were evaluated within the clinical trials and real-world studies respectively. Six clinical trials evaluated outcomes in the second-line setting, one in the third-line, three in a mix of second-line and above, and seven did not report the specific treatment line(s). There were no real-world studies exclusively in the second-line setting, one in the third-line, three in a mix of second-line and above, and two did not report the specific treatment line(s). Ramucirumab + docetaxel was the only treatment regimen evaluated in both the clinical trial and real-world studies. In the real-world studies, nivolumab was the most common treatment evaluated (n = 3). The real-world studies were conducted in India (n = 2), China, Colombia, Germany, and the United States. The overall response rate (ORR) ranged from 3% to 66% and a rate of > 15% was reported for one or more treatment regimens in 86% (12/14) of clinical trials. ORR ranged from 10% to 36% in real-world studies. Median progression-free survival ranged from 1 to 5 months in clinical trials and 3 to 8 months in real-world studies. In clinical trials, a median PFS of > 6 months was observed in 71% (10/14) of studies. Median overall survival (OS) ranged from 5 to 15 months in clinical trials and 3 to 18 months in real-world studies. Discontinuation due to adverse events ranged from 3-15% in clinical trials and 9-20% in real-world studies. Conclusions: Patients with stage IV NSCLC that has progressed on or after platinum-based chemotherapy experienced a limited response and a high burden of adverse events with the treatment regimens evaluated in both the clinical trial and real-world settings.
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