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Patient-reported outcomes at discontinuation of anti-angiogenesis therapy in the randomized trial of chemotherapy with bevacizumab for advanced cervical cancer: an NRG Oncology Group study
  1. Dana Chase1,
  2. Helen Q Huang2,
  3. Bradley J Monk3,
  4. Lois Michelle Ramondetta4,
  5. Richard T Penson5,
  6. Karen Gil6,
  7. Lisa M Landrum7,
  8. Mario Leitao8,
  9. Ana Oaknin9,
  10. Warner K Huh10,
  11. Heather L Pulaski11,
  12. Katina Robison12,
  13. Saketh R Guntupalli13,
  14. Debra Richardson14,
  15. Ritu Salani15,
  16. Michael W Sill2,
  17. Lari B Wenzel16 and
  18. Krishnansu Sujata Tewari17
  1. 1 Arizona Oncology, Paradise Valley, California, USA
  2. 2 NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, New York, USA
  3. 3 Ob Gyn/Gyn Onc, Creighton University School of Medicine at St Josephs Hospital and Medical Center, Phoenix, Arizona, USA
  4. 4 Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA
  5. 5 Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
  6. 6 Psychology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
  7. 7 University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA
  8. 8 Memorial Sloan-Kettering Cancer Center, New York, New York, USA
  9. 9 Vall d' Hebron Institute of Oncology, University Hospital, Barcelona, Spain
  10. 10 University of Alabama at Birmingham, Birmingham, Alabama, USA
  11. 11 Gynecological Oncology, University of Cincinnati, Cincinnati, Ohio, USA
  12. 12 Women and Infants Hospital of Rhode Island, Providence, Rhode Island, USA
  13. 13 Gynecologic Oncology, University of Colorado Cancer Center, Aurora, Colorado, USA
  14. 14 UT Southwestern Medical, Dallas, Texas, USA
  15. 15 Ob/Gyn, Ohio State University, Columbus, Ohio, USA
  16. 16 University of California Irvine School of Medicine, Irvine, California, USA
  17. 17 University of California Irvine School of Medicine, Orange, California, USA
  1. Correspondence to Dr Dana Chase, Arizona Oncology, Paradise Valley, CA 85253, USA; dana.chase{at}usoncology.com

Abstract

Introduction To describe patient-reported outcomes and toxicities at time of treatment discontinuation secondary to progression or toxicities in advanced/recurrent cervical cancer patients receiving chemotherapy with bevacizumab.

Methods Summarize toxicity, grade, and health-related quality of life within 1 month of treatment discontinuation for women receiving chemotherapy with bevacizumab in GOG240.

Results Of the 227 patients who received chemotherapy with bevacizumab, 148 discontinued study protocol treatment (90 for disease progression and 58 for toxicity). The median survival time from treatment discontinuation to death was 7.9 months (95% CI 5.0 to 9.0) for those who progressed versus 12.1 months (95% CI 8.9 to 23.2) for those who discontinued therapy due to toxicities. The most common grade 3 or higher toxicities included hematologic, gastrointestinal, and pain. Some 57% (84/148) of patients completed quality of life assessment within 1 month of treatment discontinuation. Those patients who discontinued treatment due to progression had a mean decline in the FACT-Cx TOI of 3.2 points versus 2.2 in patients who discontinued therapy due to toxicity. This was a 9.9 point greater decline in the FACT-Cx TOI scores than those who discontinued treatment due to progression (95% CI 2.8 to 17.0, p=0.007). The decline in quality of life was due to worsening physical and functional well-being. Those who discontinued treatment due to toxicities had worse neurotoxicity and pain.

Discussion Patients who discontinued chemotherapy with bevacizumab for toxicity experienced longer post-protocol survival but significantly greater declination in quality of life than those with progression. Future trial design should include supportive care interventions that optimize physiologic function and performance status for salvage therapies.

  • gynecology
  • cervical cancer
  • quality of life (PRO)/palliative care
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Footnotes

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  • Presented at This study was presented at the International Gynecologic Cancer Society (IGCS) 2016 meeting held in Lisbon, Portugal on October 29, 2016. Only the abstract was published online with the meeting proceedings.

  • Contributors Study concept and design: DC, BJM, KST, LMR, HQH, KG, LBW. Provision of materials or patients: HQH. Acquisition of data: HQH. Analysis and interpretation of data: DC, BJM, KST, LMR, HQH. Manuscript writing: DC, BJM, KST, LMR, HQH, LBW. Critical review of the manuscript: DC, BJM, KST, LMR, HQH, KG, RTP, LML, ML, WKH, HLP, KR, SRG, DR, RS, MWS, LBW, AO. Final approval of manuscript: DC, BJM, KST, LMR, HQH, KG, RTP, LML, ML, WKH, HLP, KR, SRG, DR, RS, MWS, LBW, AO.

  • Funding This study was supported by the following National Cancer Institute grants: NRG Oncology (1U10CA180822), NRG Operations (U10CA180868), and NCORP grant UG1CA189867.

  • Competing interests DC reports personal fees received from AstraZeneca, Clovis, Roche/Genentech, and Tesaro, outside of the submitted work. BJM reports personal fees received from Roche/Genentech, outside of the submitted work. RTP reports serving on a Scientific Advisory Board for Genentech/Roche. AO reports serving on advisory boards for Roche, AstraZeneca, PharmaMar, Clovis Oncology, and Tesaro and received support for travel/accommodation from Roche, AstraZeneca, and PharmaMar. WKH reports receiving personal fees as consultant for Antiva, PathoVax, and Li-Cor, outside of the submitted work. DR reports serving on the Advisory Board for Genentech and Ipsen and received personal fees, outside of the submitted report. RS reports serving on the Speaker Bureau for Genentech as well as serving on Advisory Boards for Tesaro, Clovis, AstraZeneca, and Ethicon, outside of the submitted work. KST reports serving on the Speaker’s Bureau, Advisory Board for Roche/Genentech.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available upon reasonable request. Please see Data Sharing Agreement information which has been attached as a supplemental file.

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