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Mini Oral - Gynaecological cancers 1

808MO - Paclitaxel with or without pazopanib in ovarian cancer patients with relapse during bevacizumab maintenance therapy: The GINECO randomized phase II TAPAZ study

Date

18 Sep 2020

Session

Mini Oral - Gynaecological cancers 1

Presenters

Florence Joly Lobbedez

Citation

Annals of Oncology (2020) 31 (suppl_4): S551-S589. 10.1016/annonc/annonc276

Authors

F. Joly Lobbedez1, M. Fabbro2, D. Berton3, J. Lequesne4, A. Anota5, A. Puszkiel6, A. Floquet7, M. Cancel8, H. Bourgeois9, L. Bengrine Lefevre10, B. You11, F. Pommeret12, A. Lortholary13, D. Spaeth14, J. MARTIN-BABAU15, C. Abdeddaim16, M. Kaminsky-Forrett17, D. Petran18, M. Provansal Gross19, P. Brachet1

Author affiliations

  • 1 Medical Oncology, Centre Francois Baclesse, 14076 - Caen/FR
  • 2 Medical Oncology, ICM Regional Cancer Institute of Montpellier, 34090 - Montpellier/FR
  • 3 Medical Oncology, Institut de Cancérologie de l'Ouest, 44805 - Saint Herblain/FR
  • 4 Clinical Research, Centre Francois Baclesse, 14076 - Caen/FR
  • 5 Methodology And Quality Of Life In Oncology Unit (inserm U1098) & French National Platform Quality Of Life And Cancer, CHRU Besancon - Hopital Jean Minjoz, 25030 - Besancon/FR
  • 6 Emr Ucbl/hcl 3738 ; Univ Lyon, Université Claude Bernard Lyon 1; Faculté de médecine Lyon-Sud, 69622 - LYON/FR
  • 7 Oncologie Médicale, Institute Bergonié, 33076 - Bordeaux/FR
  • 8 Medical Oncology, CHU Bretonneau Centre, Tours University, 37000 - Tours/FR
  • 9 Medical Oncology Department, Centre Jean Bernard - Clinique Victor Hugo and GINECO group France, Le Mans/FR
  • 10 Medical Oncology, Centre Georges Francois Leclerc, 21079 - DIJON/FR
  • 11 Medical Oncology, Institut de Cancérologie des Hospices Civils de Lyon (IC-HCL), CITOHL, GINECO, Univ Lyon, Université Claude Bernard Lyon 1, Faculté de médecine Lyon-Sud, EMR UCBL/HCL 3738, 3738 - Lyon/FR
  • 12 Département De Médecine Oncologique, Gustave Roussy, 94805 - VILLEJUIF/FR
  • 13 Oncologie, Centre Catherine de Sienne, Hopital privé du Confluent, 44202 - Nantes/FR
  • 14 Oncologie, Centre d'Oncologie de Gentilly, 54000 - Nancy/FR
  • 15 Medical Oncology, Centre Armoricain d'Oncologie CARIO-HPCA-BEC 22, 22190 - PLERIN/FR
  • 16 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 17 Medical Oncology, Institut de Cancérologie de Lorraine - Alexis Vautrin, 54519 - Vandoeuvre les Nancy/FR
  • 18 Medical Oncology, Hôpital de Mont-de-Marsan, 40024 - Mont-de-Marsan/FR
  • 19 Medical Oncology, Institute Paoli Calmettes, 13009 - Marseille/FR
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Resources

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Abstract 808MO

Background

Anti-angiogenic rechallenge combining bevacizumab and chemotherapy is efficient among relapse Ovarian Cancer (OC) patients (pts). However few data are available with tyrosine kinase inhibitors if progression during bevacizumab maintenance.

Methods

TAPAZ is a French randomized (2:1) phase II trial including recurrent OC pts during the first year of bevacizumab maintenance therapy in 1st or 2nd line, comparing weekly paclitaxel 65 mg/m2 with pazopanib 600 to 800 mg daily (PP arm) to weekly paclitaxel 80mg/m2 (P arm). Primary endpoint was Progression-Free-Survival (PFS). Main secondary endpoints were Overall Survival (OS), safety, pharmacokinetic, and Quality of Life (QoL).

Results

116 pts were enrolled, 79 in PP and 37 in P arms. Median age was 65 y [42-85], relapse < 6months (mo) 70%, serous histology 88%, FIGO III/IV 98%. With a median follow-up of 12.8 mo [1-47], median PFS was 4.6 mo [3.9-6.1] in PP arm vs 5.5 mo [4.8-7.3] in P arm (p=0.6) and OS 13.5 vs 12.8 mo, respectively (p=0.77). Weekly median dose of Paclitaxel was 65 mg/m2 in PP arm and 80 mg/m2 in P arm. 14% of pts in PP arm received 800 mg of daily Pazopanib. 81% of pts in P arm stopped treatment because of progression vs 66% (p =0.09). G3/4 toxicities were more frequent in PP arm (87% vs 70%, p=0.03). Treatments discontinuation for toxicity was 47% in PP arm (including the 2 drugs in 19%) vs 12% in P arm (p<0.001). In PP arm, discontinuation was mainly due to digestive (31%), vascular (thrombosis, HBP) (28%) and hematologic (17%) disorders, with 3 sepsis and 2 toxic deaths (pulmonary embolism and digestive perforation). More significant deterioration of global QoL and diarrhea at 4 mo was reported in PP arm (mean change: -9 [-14; -3], p=0.003 and 11 [2-19], p=0.01, respectively). In PP arm, PFS and OS were not related to pazopanib plasma exposure at cycle 1 (p=0.7 and 0.5) but pts experiencing vomiting at cycle 1 had higher pazopanib exposure (p=0.01).

Conclusions

Addition of pazopanib to paclitaxel in recurrent OC pts progressing during bevacizumab maintenance is not superior to paclitaxel. It increases toxicity and compromises chemotherapy efficacy leading to more frequent early treatment discontinuations.

Clinical trial identification

EudraCT 2014-003843-37; NCT02383251 (First posted: March 2015, Last Update: January 2020).

Editorial acknowledgement

Legal entity responsible for the study

ARCAGY-GINECO.

Funding

ARCAGY-GINECO, Novartis.

Disclosure

F. Joly Lobbedez: Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Pfizer; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: BMS; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Honoraria (institution), Advisory/Consultancy: Astellas; Honoraria (institution), Advisory/Consultancy, Travel/Accommodation/Expenses: Janssen; Honoraria (institution), Advisory/Consultancy: Bayer; Advisory/Consultancy, Travel/Accommodation/Expenses: Sanofi; Advisory/Consultancy, Travel/Accommodation/Expenses: Ipsen; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: GSK; Advisory/Consultancy: Clovis. M. Fabbro: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: GSK. D. Berton: Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Tesaro; Travel/Accommodation/Expenses, ESMO: Pfizer; Travel/Accommodation/Expenses, ESCO: PharmaMar. A. Anota: Honoraria (self): Roche; Honoraria (self), Research grant/Funding (self), Travel/Accommodation/Expenses: BMS; Honoraria (self), Advisory/Consultancy: Sandoz; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Travel/Accommodation/Expenses: Pfizer/Hospira; Travel/Accommodation/Expenses: Novartis. A. Puszkiel: Full/Part-time employment: Hospices Civils de Lyon, Groupement Hospitalier Sud. A. Floquet: Advisory/Consultancy, Travel/Accommodation/Expenses: Tesaro; Advisory/Consultancy: Clovis; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: GSK; Advisory/Consultancy, Travel/Accommodation/Expenses, Non-remunerated activity/ies: MSD; Travel/Accommodation/Expenses, Non-remunerated activity/ies: Roche. L. Bengrine Lefevre: Honoraria (institution), Full/Part-time employment: Centre Georges Francois Leclerc (hospital); Advisory/Consultancy: AstraZeneca. B. You: Honoraria (institution): HCL & Université de Lyon; Advisory/Consultancy, Travel/Accommodation/Expenses: AstraZeneca; Advisory/Consultancy: GSK; Advisory/Consultancy: Novartis; Advisory/Consultancy, Travel/Accommodation/Expenses: Bayer; Advisory/Consultancy: Roche; Advisory/Consultancy: Clovis; Advisory/Consultancy: Amgen; Advisory/Consultancy, Travel/Accommodation/Expenses: MSD; Advisory/Consultancy: ECS Progastrin; Research grant/Funding (institution): Gineco. A. Lortholary: Honoraria (self): GSK; Honoraria (self): Roche; Honoraria (self): Novartis. D. Spaeth: Honoraria (self): Astra; Travel/Accommodation/Expenses: Pfizer. C. Abdeddaim: Advisory/Consultancy: GSK/Tesaro; Advisory/Consultancy: BMS; Advisory/Consultancy, Travel/Accommodation/Expenses: Merck. M-C. Kaminsky-Forrett: Honoraria (self): Tesaro; Honoraria (self): AstraZeneca; Travel/Accommodation/Expenses: Merck. D. Petran: Travel/Accommodation/Expenses, Congrès, Réunions: Amgen; Travel/Accommodation/Expenses, Congrès, Réunions: Sandoz; Travel/Accommodation/Expenses, Congrès, Réunions: Pfizer; Travel/Accommodation/Expenses, Congrès, Réunions: Ipsen; Travel/Accommodation/Expenses, Congrès, Réunions: Roche; Travel/Accommodation/Expenses, Congrès, Réunions: BMS. P-E. Brachet: Advisory/Consultancy: BMS; Advisory/Consultancy: AstraZeneca. All other authors have declared no conflicts of interest.

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