Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology

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Abstract

Progression-free survival (PFS) has become a commonly used outcome to assess the efficacy of new cancer drugs. However, it is not clear if delay in progression leads to improved quality of life with or without overall survival benefit.

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Improved survival with bevacizumab in advanced cervical cancer.

Krishnansu Tewari, Michael Sill, Harry J Long … (2014)

Vascular endothelial growth factor (VEGF) promotes angiogenesis, a mediator of disease progression in cervical cancer. Bevacizumab, a humanized anti-VEGF monoclonal antibody, has single-agent activity in previously treated, recurrent disease. Most patients in whom recurrent cervical cancer develops have previously received cisplatin with radiation therapy, which reduces the effectiveness of cisplatin at the time of recurrence. We evaluated the effectiveness of bevacizumab and nonplatinum combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer. Using a 2-by-2 factorial design, we randomly assigned 452 patients to chemotherapy with or without bevacizumab at a dose of 15 mg per kilogram of body weight. Chemotherapy consisted of cisplatin at a dose of 50 mg per square meter of body-surface area, plus paclitaxel at a dose of 135 or 175 mg per square meter or topotecan at a dose of 0.75 mg per square meter on days 1 to 3, plus paclitaxel at a dose of 175 mg per square meter on day 1. Cycles were repeated every 21 days until disease progression, the development of unacceptable toxic effects, or a complete response was documented. The primary end point was overall survival; a reduction of 30% in the hazard ratio for death was considered clinically important. Groups were well balanced with respect to age, histologic findings, performance status, previous use or nonuse of a radiosensitizing platinum agent, and disease status. Topotecan-paclitaxel was not superior to cisplatin-paclitaxel (hazard ratio for death, 1.20). With the data for the two chemotherapy regimens combined, the addition of bevacizumab to chemotherapy was associated with increased overall survival (17.0 months vs. 13.3 months; hazard ratio for death, 0.71; 98% confidence interval, 0.54 to 0.95; P=0.004 in a one-sided test) and higher response rates (48% vs. 36%, P=0.008). Bevacizumab, as compared with chemotherapy alone, was associated with an increased incidence of hypertension of grade 2 or higher (25% vs. 2%), thromboembolic events of grade 3 or higher (8% vs. 1%), and gastrointestinal fistulas of grade 3 or higher (3% vs. 0%). The addition of bevacizumab to combination chemotherapy in patients with recurrent, persistent, or metastatic cervical cancer was associated with an improvement of 3.7 months in median overall survival. (Funded by the National Cancer Institute; GOG 240 ClinicalTrials.gov number, NCT00803062.).

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The nuts and bolts of PROSPERO: an international prospective register of systematic reviews

Alison Booth, Mike Clarke, Gordon Dooley … (2012)

Background Following publication of the PRISMA statement, the UK Centre for Reviews and Dissemination (CRD) at the University of York in England began to develop an international prospective register of systematic reviews with health-related outcomes. The objectives were to reduce unplanned duplication of reviews and provide transparency in the review process, with the aim of minimizing reporting bias. Methods An international advisory group was formed and a consultation undertaken to establish the key items necessary for inclusion in the register and to gather views on various aspects of functionality. This article describes the development of the register, now called PROSPERO, and the process of registration. Results PROSPERO offers free registration and free public access to a unique prospective register of systematic reviews across all areas of health from all around the world. The dedicated web-based interface is electronically searchable and available to all prospective registrants. At the moment, inclusion in PROSPERO is restricted to systematic reviews of the effects of interventions and strategies to prevent, diagnose, treat, and monitor health conditions, for which there is a health-related outcome. Ideally, registration should take place before the researchers have started formal screening against inclusion criteria but reviews are eligible as long as they have not progressed beyond the point of completing data extraction. The required dataset captures the key attributes of review design as well as the administrative details necessary for registration. Submitted registration forms are checked against the scope for inclusion in PROSPERO and for clarity of content before being made publicly available on the register, rejected, or returned to the applicant for clarification. The public records include an audit trail of major changes to planned methods, details of when the review has been completed, and links to resulting publications when provided by the authors. Conclusions There has been international support and an enthusiastic response to the principle of prospective registration of protocols for systematic reviews and to the development of PROSPERO. In October 2011, PROSPERO contained 200 records of systematic reviews being undertaken in 26 countries around the world on a diverse range of interventions.

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Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205.

Philip Philip, Jacqueline K Benedetti, Christopher L Corless … (2010)

Patients with advanced pancreas cancer present with disease that is poorly responsive to conventional therapies. Preclinical and early clinical evidence has supported targeting the epidermal growth factor receptor (EGFR) signaling pathway in patients with pancreas cancer. This trial was conducted to evaluate the contribution of an EGFR-targeted agent to standard gemcitabine therapy. Cetuximab is a monoclonal antibody against the ligand-binding domain of the receptor. Patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma were randomly assigned to receive gemcitabine alone or gemcitabine plus cetuximab. The primary end point was overall survival. Secondary end points included progression-free survival, time to treatment failure, objective response, and toxicity. A total of 745 eligible patients were accrued. No significant difference was seen between the two arms of the study with respect to the median survival time (6.3 months for the gemcitabine plus cetuximab arm v 5.9 months for the gemcitabine alone arm; hazard ratio = 1.06; 95% CI, 0.91 to 1.23; P = .23, one-sided). Objective responses and progression-free survival were similar in both arms of the study. Although time to treatment failure was longer in patients on gemcitabine plus cetuximab (P = .006), the difference in length of treatment was only 2 weeks longer in the combination arm. Among patients who were studied for tumoral EGFR expression, 90% were positive, with no treatment benefit detected in this patient subset. In patients with advanced pancreas cancer, the anti-EGFR monoclonal antibody cetuximab did not improve the outcome compared with patients treated with gemcitabine alone. Alternate targets other than EGFR should be evaluated for new drug development.

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Author and article information

Journal

Title: JAMA Internal Medicine

Abbreviated Title: JAMA Intern Med

Publisher: American Medical Association (AMA)

ISSN (Print): 2168-6106

Publication date Created: December 01 2018

Publication date (Print): December 01 2018

Volume: 178

Issue: 12

Page: 1586

Affiliations

[1 ]Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Ontario, Canada

[2 ]Alberta PROMs & EQ-5D Research & Support Unit, School of Public Health, University of Alberta, Li Ka Shing Centre for Health Research Innovation, Edmonton, Alberta, Canada

[3 ]Department of Diagnostic Radiology, University of Toronto, Toronto, Ontario, Canada

[4 ]Department of General Surgery, Université de Sherbrooke, Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada

[5 ]2nd Department of General Surgery, Jagiellonian University Medical College, Krakow, Poland

[6 ]Centre for Research, Training and Innovation in Surgery (CERTAIN Surgery), Krakow, Poland

[7 ]Department of General Medicine, Kurashiki Central Hospital, Miwa Kurashiki Okayama, Japan

[8 ]High Institute of Public Health, Alexandria University, Al Ibrahimeyah Qebli WA Al Hadrah Bahri Qesm Bab Sharqi, Alexandria Governorate, Egypt

[9 ]Drug Information Center, Tanta Chest Hospital, Ministry of Health, Tanta, Egypt

[10 ]Department of Medicine, McMaster University, Hamilton, Ontario, Canada

[11 ]Department of Surgery, Okinawa Prefectural Nanbu Medical Center & Children’s Medical Center, Haebaru-cho, Shimajiri-gun, Okinawa, Japan

[12 ]Department of Clinical Epidemiology, Kyoto University Graduate School of Medicine/School of Public Health, Yoshida Konoe-cho, Sakyo-ku, Kyoto, Japan

[13 ]Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Toronto, Toronto, Ontario, Canada

[14 ]Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada

[15 ]Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada

[16 ]Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada

[17 ]Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Huangpu District, Shanghai, People’s Republic of China

[18 ]Accident and Emergency Department, Queen Mary Hospital, High West, Hong Kong

[19 ]Research Ethics in Medicine Study Group (REMEDY), Department of Philosophy and Bioethics, Jagiellonian University Medical College, Krakow, Poland

[20 ]Centre for Community Medicine, All India Institute of Medical Sciences, New Delhi, India

[21 ]Health Sciences Library, McMaster University, Hamilton, Ontario, Canada

[22 ]Biostatistics Unit/FSORC, St Joseph’s Healthcare Hamilton, Hamilton, Ontario, Canada

[23 ]Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada

[24 ]Department of Pediatrics, McMaster University, Hamilton, Ontario, Canada

[25 ]Population Health Research Institute, Hamilton Health Sciences, Hamilton, Ontario, Canada

[26 ]Kingston Health Sciences Centre, Cancer Centre of Southeastern Ontario, Kingston General Hospital, Kingston, Ontario, Canada

[27 ]Cancer Research Institute, Queen’s University at Kingston, Kingston, Ontario, Canada

[28 ]Centre for Health Economics and Policy Analysis, McMaster University, Hamilton, Ontario, Canada

[29 ]Programs for Health Economics and Outcome Measures, Hamilton, Ontario, Canada

Article

DOI: 10.1001/jamainternmed.2018.4710

PMC ID: 6583599

PubMed ID: 30285081

SO-VID: 4fa67134-6ef9-46f3-a307-e64a2f4a0468

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Evaluating Progression-Free Survival as a Surrogate Outcome for Health-Related Quality of Life in Oncology : A Systematic Review and Quantitative Analysis

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Abstract

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Karger: Oncology

Most cited references 55

Improved survival with bevacizumab in advanced cervical cancer.

The nuts and bolts of PROSPERO: an international prospective register of systematic reviews

Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205.

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Cited by 46

Most referenced authors 1,888