First‐line gemcitabine and carboplatin in advanced ovarian carcinoma: a phase II study

Abstract

Objectives To evaluate tumour response rate and toxicities of gemcitabine and carboplatin in chemonaive subjects with advanced epithelial ovarian cancer.Design A phase II study.Setting Gynaecologic oncologic unit.Population Twenty chemonaive International Federation of Gynecology and Obstetrics (FIGO) stage IIIc and stage IV subjects with ovarian cancer.Main outcome measures Tumour response, disease free and overall survival and toxicity.Methods Intravenous gemcitabine 1000 mg/m 2 on day 1 and day 8 and carboplatin at area under centre (AUC) = 5 on day 1 were administered three weekly for six cycles. Subjects who received more than three cycles of chemotherapy were eligible for assessment of tumour response, while all the cycles of chemotherapy were assessed for toxicities.Results The mean age of the subjects was 57.3 years, and the median follow up was 38.7 months. Of the 18 eligible subjects analysed, 11 (61.1%) showed a complete clinical response, and the overall response rate was 83.3% (15/18). The median overall survival was 29.2 [95% (confidence interval) CI 22.8-35.6] months, and the median progression-free survival was 11.6 (95% CI 4.7-18.5) months. WHO grade 3 anaemia, neutropenia and thrombocytopenia was 7.6, 9.5 and 0%, respectively, on day 8, and 15.5, 12.2 and 15.5%, respectively, on day 15. Two subjects required a total of three hospital admissions for neutropenic sepsis, and two required five hospital admissions for platelet transfusion for severe thrombocytopenia.Conclusion Chemonaive advanced ovarian cancer showed a high response rate to combined gemcitabine and carboplatin chemotherapy. The subjects developed moderate adverse reactions. Phase III study to evaluate the role of combined gemcitabine and carboplatin as first-line chemotherapy in ovarian cancer is warranted.

Eltrombopag with gemcitabine‐based chemotherapy in patients with advanced solid tumors: a randomized phase I study

“…However, persistence of platelet counts ≤100 × 10 9 /L frequently occurs and generally necessitates dose delays and/or reductions . Studies have demonstrated that Grades 3 and 4 thrombocytopenia occur in between 16% and 55% of patients receiving gemcitabine/platinum treatment regimens , and 3–16% of patients receiving single‐agent gemcitabine . Previous attempts to use thrombopoietin‐stimulating agents have been successful at maintaining dose intensity, although antibody formation limited the use of these agents .…”

Metallodrugs in cancer nanomedicine

“…145 Among them, the cisplatin or carboplatin plus paclitaxel combination has shown clinical promise for treating multiple cancers including non-small-cell lung (NSCLC), ovarian, cervical, gastric, breast and metastatic esophageal carcinomas. [179][180][181][182][183][184] Other relevant examples include cisplatin plus docetaxel and 5-FU (DNA repair targeting agent) for locally advanced head, neck and anal squamous cell carcinoma, 185,186 and carboplatin plus gemcitabine for the treatment of advanced ovarian cancer; 187,188 both combinations approved in 2006.…”

Chemotherapy Resistance in Advanced Ovarian Cancer Patients

“…46 Gemcitabine, a nucleoside analogue, and carboplatin also showed significant CR. 51 Carboplatin and topotecan, which is a specific topoisomerase I inhibitor that causes single-stranded breaks in DNA during replication, showed a CR of 71%. 57…”