Annals of Oncology 12:541-547, 2001
© 2001 European Society for Medical Oncology
research-article |
A phase II study of gemcitabine and cisplatin combination as induction chemotherapy for untreated locally advanced cervical carcinoma
1Departments of Medical Oncology, Gvnecology, Radiotherapy, Pathology and Basic Research, Institute Nacional de Cancerologia
2Department of Genetics and Environmental Toxicology IIB, UNAM, Mexico City, Mexico
Correspondence to: Dr A Dueñas-Gonzalez, Instituto Nacional de Cancerologia, Subdirección de Investigacion BasicaSan Fernando #22, Tlalpan 14080, Mexico D F E-mail alduenas{at}dfl.telmex.net.mx
Background Cisplatin-based chemoradiation for locally advanced cervical carcinoma is now the standard of care for most patients with cervical carcinoma However, induction chemotherapy followed by surgery, particularly with newer agents or combinations remains to be explored This study was undertaken to evaluate the antitumor activity and toxicity of gemcitabine in combination with cisplatin for untreated locally advanced cervical carcinoma
Patients and methods Open-label, single center, phase II, non-randomized study of neoadjuvant gemcitabine plus cisplatin Forty-one patients with histologic diagnosis of cervical carcinoma, with no previous treatment and staged as IB2 to lllB, were treated with three 21-day courses of cisplatin 100 mg/m2 day 1 and gemcitabine 1000 mg/m2 days 1 and 8, followed by locoregional treatment with either surgery or
concomitant chemoradiation Response and toxicity were evaluated before each course and at the end of chemotherapy
Results All patients were evaluated for toxicity and 40 for response The overall objective response rate was 95% (95% confidence interval (Cl) 88%-100%) being complete in 3 patients (7 5%) and partial in 35 (87 5%) A complete pathological response was found in 6 (26%) of the 23 patients that underwent surgery Granulocytopenia grades 3–4 occurred in 13 8% and 3 4% of the courses, respectively, whereas non-hematolog-lcal toxicity was mild
Conclusions Induction chemotherapy with the combination of gemcitabine and cisplatin is highly active for untreated cervical cancer patients and has an acceptable toxicity profile
cervical cancer, gemcitabine cisplatin, neoadjuvant chemotherapy
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