Phase II study of gemcitabine and cisplatin in chemonaive patients with advanced epithelial ovarian cancer

Nogué, Miquel; Cirera, Lluís; Arcusa, Àngels; Batiste-Alentorn, E.; Balil, A.; Font, Albert; Perez-Gracia, José Luis; Carrasco, Eva; Tusquets, Ignasi

doi:10.1097/00001813-200209000-00009

Cited by 25 publications

(10 citation statements)

References 15 publications

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“…The synergy (10 -12) and clinical activity of systemic cisplatin and gemcitabine in patients with ovarian cancer are well described both in the chemotherapy-naive and relapse populations (13,14). Several characteristics of gemcitabine have suggested that it is a reasonable candidate for exploration in the i.p.…”

Section: Introductionmentioning

confidence: 99%

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

Sabbatini¹,

Aghajanian²,

Leitao³

et al. 2004

Clinical Cancer Research

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Purpose: The aims of this study were to determine the dose and schedule of i.p. cisplatin with i.p. gemcitabine in patients with persistent disease at second-look assessment, the toxicity of this regimen, and the time to treatment failure and overall survival.Experimental Design: We performed a Phase I/II evaluation of i.p. cisplatin at 75 mg/m 2 on day 1 with planned gemcitabine at 500, 750, 1000, or 1250 mg/m 2 i.p. on days 1, 8, and 15 on a 28-day schedule for four courses. Eligible patients completed surgical cytoreduction followed by adjuvant platinum-based chemotherapy. They had second-look assessment showing microscopic or macroscopic (<1 cm) disease, followed by i.p. port placement.Results: The Phase I dose-limiting toxicity was grade 3 thrombocytopenia at day 15 on dose level 1 (n ‫؍‬ 5). The protocol was amended, and the Phase II portion accrued to 30 patients, who were given i.p. cisplatin (75 mg/m 2 ) on day 1 and gemcitabine at 500 mg/m 2 on days 1 and 8 on a 21-day schedule for four courses. Nine patients were removed from the study: one each for hypersensitivity, cellulitis, and i.p. port malfunction; two for progression of disease; and four for renal toxicity. Other toxicities included grade 3 nausea (7%) and transient grade 3 neuropathy (3%). Grade 1 or 2 neuropathy was frequently seen (80%). Conclusions: The median time to treatment failure and overall survival of 15.9 months and 43.5 months, respectively, are consistent with our historical data in patients receiving i.p. platinum-based regimens for consolidation. The fibrotic changes seen in explored patients suggest local toxicity of this combination. The absolute benefit of i.p. consolidation requires randomized trials to assess efficacy.

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Section: Introductionmentioning

confidence: 99%

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

Sabbatini¹,

Aghajanian²,

Leitao³

et al. 2004

Clinical Cancer Research

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“…More interestingly, our results are very similar to the experience of Bauknecht et al , who, in a phase II study with gemcitabine and cisplatin as first‐line treatment of people older than 60 years with FIGO stage IIIC or stage IV epithelial ovarian carcinoma, found an overall response rate of 62.2% (95% CI, 44.8–77.5%) and a median survival of 27.7 months (95% CI, 14.3–40.8 months) 18 . Also, Nogue et al reported a similar study with gemcitabine and cisplatin, with an overall clinical response rate of 70.7% (95% CI 56.8–84.6%), a median overall survival of 23.4 months (95% CI 15.9–29.9 months) and a median progression‐free survival time of 10.4 months (95% CI 9.4–13.5 months) 19 . In this respect, our study suggests that the combination of gemcitabine and carboplatin seems to be as efficacious as combined gemcitabine and cisplatin; in the same way, paclitaxel and carboplatin is equally efficacious as paclitaxel and cisplatin 20…”

Section: Discussionmentioning

confidence: 82%

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

Tay

Ilanchadran

Tan

2006

BJOG

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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.

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“…In NSCLC, the use of a 3 weekly regimen results in significantly fewer dose delays and reductions (19 vs 51%), improved dose intensity, similar response rates and reduced grade 3/4 thrombocytopenia (6 vs 30%) than a 4 weekly one. This combination has also been tested in ovarian cancer (Nogue et al, 2002), transitional cell carcinoma (Lorusso et al, 2000) and pancreatic cancer. In the latter, a response rate of 11% was observed with stable disease in 57% (Heinemann et al, 2000).…”

Section: à2mentioning

confidence: 99%

Phase II study of gemcitabine and cisplatin in locally advanced/metastatic oesophageal cancer

et al. 2005

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Palliative chemotherapy for inoperable/metastatic oesophageal cancer has limited activity. This study assesses the feasibility and activity of gemcitabine and cisplatin in this group of patients. In total, 42 patients with locally advanced/metastatic squamous or adenocarcinoma of the oesophagus were treated with gemcitabine 1250 mg m À2 days 1 and 8 and cisplatin 75 mg m À2 day 1 in a 21-day cycle. Interim safety analysis was carried out after the first 19 patients suggested significant toxicity. The dose of gemcitabine was subsequently reduced to 1000 mg m À2 . Patients were assessed for toxicity and response. The median number of treatment cycles per patient was 4 (range 1 -6). Grade 3 -4 neutropenia occurred in 37% of cycles; however, there was only one episode of neutropenic fever. Nonhaematological toxicities included fatigue, nausea and vomiting. Among 32 patients eligible for response, there were three complete responses and 16 partial responses (overall response rate of 45%); nine patients had stable disease. Median survival was 11 months. The response rate appears to be greatest in those with squamous carcinoma compared to adenocarcinoma (71 vs 33%, P ¼ 0.036). The combination of gemcitabine and cisplatin in this schedule has manageable toxicity and significant activity in patients with locally advanced/metastatic oesophageal cancer and is worthy of further study.

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Phase II study of gemcitabine and cisplatin in chemonaive patients with advanced epithelial ovarian cancer

Cited by 25 publications

References 15 publications

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

Intraperitoneal Cisplatin with Intraperitoneal Gemcitabine in Patients with Epithelial Ovarian Cancer

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

Phase II study of gemcitabine and cisplatin in locally advanced/metastatic oesophageal cancer

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