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Original Investigation
October 8, 2020

Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate Among Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial

Author Affiliations
  • 1GINECO and Centre Léon Bérard, University Claude Bernard Lyon 1, Lyon, France
  • 2AGO Study Group and Ev Kliniken Essen-Mitte, Essen, Germany
  • 3MITO and Istituto Nazionale Tumori, Milan, Italy
  • 4GINECO and Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France
  • 5BGOG and University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium
  • 6GOTIC and Saitama Medical University International Medical Center, Hidaka, Japan
  • 7GINECO and Institut Claudius Regaud, IUCT-Oncopole, Toulouse, France
  • 8AGO Study Group and Gyneco-Oncological Practice, Hannover, Germany
  • 9GINECO and Institut Bergonié, Bordeaux, France
  • 10GINECO and Centre Oscar Lambret, Lille, France
  • 11AGO Study Group and Frauenklinik Technical University Munich, Munich, Germany
  • 12Current, RoMed Klinikum Rosenheim, Rosenheim, Germany
  • 13MITO and Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Napoli, Italy
  • 14GINECO and Groupe Hospitalier Diaconesses Croix Saint-Simon, Paris, France
  • 15AGO Study Group and Medical University of Berlin, Charité–CVK, Berlin, Germany
  • 16GINECO and Centre Oncologie de Gentilly, Nancy, France
  • 17MITO and Ospedale San Raffaele, Milan, Italy
  • 18GINECO and Gustave Roussy, Villejuif, France
  • 19MITO and Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori IRST IRCCS, Meldola, Italy
  • 20GINECO and Institut Paoli Calmettes, Marseille, France
  • 21GINECO and Centre Léon Bérard, Lyon, France
JAMA Oncol. Published online October 8, 2020. doi:10.1001/jamaoncol.2020.4574
Visual Abstract. Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate for Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial
Effect of Weekly Paclitaxel With or Without Bevacizumab on Progression-Free Rate for Patients With Relapsed Ovarian Sex Cord-Stromal Tumors: The ALIENOR/ENGOT-ov7 Randomized Clinical Trial
Key Points

Question  What is the efficacy of weekly paclitaxel, with or without bevacizumab, as treatment for relapsed sex cord-stromal tumors?

Findings  In this randomized clinical trial including 60 women with relapsed sex cord-stromal tumors, adding bevacizumab to weekly paclitaxel did not improve 6-month progression-free rate (primary end point; 71% vs 72%) or progression-free survival.

Meaning  Through international collaboration, a randomized trial was conducted in this very rare cancer showing that weekly paclitaxel is a new option for relapsed sex cord-stromal tumors.

Abstract

Importance  To our knowledge, this is the first randomized trial in sex cord-stromal tumors, and it establishes weekly paclitaxel as standard-of-care therapy after platinum-based therapy in this setting.

Objective  To determine the efficacy of weekly paclitaxel with or without bevacizumab as treatment for relapsed sex cord-stromal tumors and evaluate whether the addition of bevacizumab to weekly paclitaxel improves 6-month progression-free rate.

Design, Setting, and Participants  This open-label, academic, international, randomized phase 2 trial (ALIENOR) was conducted at 28 referral centers in France, Germany, Italy, Japan, and Belgium in collaboration with the Rare Tumor committee of the Gynecologic Cancer InterGroup and used an adaptive bayesian design. It included 60 women with sex cord-stromal tumors that had relapsed after at least 1 platinum-based chemotherapy. Enrollment occurred from 2013 to 2016, and the final analysis database lock was on March 27, 2020 (median follow-up, 38.9 months).

Interventions  Participants were randomized to receive either paclitaxel (80 mg/m2, days 1, 8, and 15 every 4 weeks) alone or paclitaxel with bevacizumab (10 mg/kg, every 2 weeks) for 6 cycles followed by maintenance bevacizumab (15 mg/kg, every 3 weeks) for up to 1 year or until progression or unacceptable toxicity. Crossover to bevacizumab was permitted after progression during or following paclitaxel alone.

Main Outcomes and Measures  Six-month progression-free rate.

Results  Sixty patients (predominantly with granulosa cell tumors) were randomized, 32 to receive single-agent paclitaxel (median [interquartile range] age at inclusion, 60 [53-64] years) and 28 to receive paclitaxel-bevacizumab (median [interquartile range] age at inclusion, 55 [47-61] years; 1 did not receive treatment). The estimated 6-month progression-free rate was 71% (95% credible interval, 55%-84%) with paclitaxel alone and 72% (95% credible interval, 55%-87%) with paclitaxel-bevacizumab. The bayesian estimate for the probability that the 6-month progression-free rate distribution was higher with the combination than with paclitaxel alone was 57%, less than the predefined superiority threshold. The objective response rate increased from 25% (95% CI, 12%-43%) to 44% (95% CI, 26%-65%) with the addition of bevacizumab. One patient discontinued combination therapy within 6 months because of toxicity.

Conclusions and Relevance  Weekly paclitaxel is a new option for relapsed sex cord-stromal tumors. In this international randomized clinical trial of patients with relapsed sex cord-stromal tumors unsuitable for surgery, adding bevacizumab to weekly paclitaxel does not improve clinical benefit.

Trial Registration  ClinicalTrials.gov Identifier: NCT01770301

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