Background: Chemoradiation is the standard treatment for locally-advanced cervical cancer. Neoadjuvant chemotherapy is an alternative, with a 14% absolute improvement in survival, especially when intense and short.
Methods: Since 2006, 83 patients were enrolled in this multicentric prospective phase II study. Eligibility criteria: squamous or adenosquamous cervical carcer; stages IB2, IIA, IIB; ECOG PS≤2; neutrophils ≥1,500 /µL; platelets ≥100,000/µL, normal renal and liver function.
Treatment consisted of 6 weekly courses of Topotecan (2 mg/m2) and Cisplatin (40 mg/m2). All responsive and stable patients were submitted to radical surgery, while progressed underwent definitive radiotherapy±chemotherapy. Primary endpoint was evaluation of efficacy and toxicity .
Results: Mean age was 48 years. Clinical FIGO Stage: 25 IB2; 11 IIA; 47 IIB. Suspicious lymph nodes at MRI were 35%. Ninety-six percent of patients received 6 courses, 98% of cycles were delivered at a full dose, without any delay in 96%. Treatment was well tolerated, no death occurred. G3-G4 bone marrow toxicity was observed in 4% of cycles. Clinical response rate was 81%. Five progressive cases and 3 partial responses with severe co-morbidities were treated with radiotherapy±chemotherapy, the others underwent radical surgery. Overall pathological response rate was 64%, with 25% of optimal responses. Nodal metastases occurred in 37% of patients. Forty-four percent of patients received adjuvant therapy because of negative prognostic factors. Mean follow-up is 20 months, 84% of patients are free from recurrence, 18% relapsed and 4% died.
Conclusions: Weekly Topotecan and Cisplatin showed an acceptable toxicity and a promising response rate.
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