Dose-dense paclitaxel/carboplatin as neo-adjuvant chemotherapy followed by radical surgery in locally advanced cervical cancer: a prospective phase II study

Gabriella Ferrandina, Giacomo Corrado, Giuseppe Vitrano, Valerio Gallotta, Eleonora Palluzzi, Mariagrazia Distefano, Giovanni Scambia

Research output: Contribution to journalArticle

Abstract

Purpose: The role of dose-dense schedules in the neo-adjuvant treatment (NACT) of locally advanced cervical cancer (LACC) has been reported. This phase II study investigated activity of dose-dense paclitaxel/platinum before radical surgery (RS) in LACC patients. Methods: The primary end-point was the rate of optimal pathological response (OPR: pathological complete/microscopic response). NACT (paclitaxel: 80 mg/m2) and carboplatin (AUC 2) were administered for 6 weeks. Overall response rate (ORR) to NACT was assessed by the RECIST criteria. Patients amenable to surgery were triaged to RS. The null hypothesis was that the OPR rate would improve from 30.0 to 45.0% (α error: 0.05, β error: 0.2). The regimen would be considered active if > 25 OPRs were found. Results: 36 patients were enrolled; 19 patients were stage IIB (52.8%) and 16 (44.4%) patients had pelvic lymph-node involvement at imaging. All patients completed neo-adjuvant chemotherapy; ORR was of 75.0%. RS was performed in 29 (93.5%) patients. Since the OPR was 16.1%, we evaluated the real chances to achieve the number of OPR required by the Simon design and decided to close the study. Grade 3/4 hematological toxicity occurred in 5 patients; surgical morbidity occurred in 14 patients. The 2-year PFS rate was 69.0%. Conclusion: Dose-dense neo-adjuvant paclitaxel/carboplatin is feasible and safe in LACC patients; however, failure to achieve the primary end-point has to be recognized. Given the heterogeneity of the available studies, robust data from an adequately sized prospective study focused on more homogeneous series are required.

Original languageEnglish
JournalCancer Chemotherapy and Pharmacology
DOIs
Publication statusAccepted/In press - Jan 1 2018

Keywords

  • Dose density
  • Locally advanced cervical cancer
  • Neo-adjuvant chemotherapy
  • Personalized medicine
  • Radical hysterectomy

ASJC Scopus subject areas

  • Oncology
  • Toxicology
  • Pharmacology
  • Cancer Research
  • Pharmacology (medical)

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