Progression-free survival as a surrogate endpoint of overall survival in patients with metastatic colorectal cancer

Abstract

BackgroundIn many clinical trials designed to assess the efficacy of anticancer treatments, overall survival (OS) is often used as a primary endpoint despite its several points of weakness.MethodsThis study evaluated the role of progression-free survival (PFS) in the first three lines of treatment as a potential surrogate endpoint of OS in patients with metastatic colorectal cancer (MCRC). One hundred and twenty patients with MCRC were enrolled in this study. The median PFS of the first-, second-, and third-lines of treatment and the OS were evaluated. The correlation between the time to progression and the OS was analyzed. The median PFS of the three lines of treatment were 8.5, 5, and 3 months, respectively.ResultsThe median OS was 32.4 months. A modest correlation was found between the PFS to the first-line treatment with Folfox–avastin and OS. Similar data were obtained with the second-line treatment. However, no correlation was found between the PFS and OS during the third-line treatment. The regression analysis revealed that PFS is predictive of OS.ConclusionIn brief, the PFS of the first- and second-lines of treatment could be a good candidate as a surrogate endpoint of OS in patients with MCRC.

Effect of High-Dose vs Standard-Dose Vitamin D3 Supplementation on Progression-Free Survival Among Patients With Advanced or Metastatic Colorectal Cancer

“…Progression-free survival was chosen as the primary end point because the primary objective of the trial was to evaluate the difference between high-dose and standarddose vitamin D 3 when given with chemotherapy as part of firstline therapy, and because progression-free survival has been shown to be a surrogate for overall survival. 11 Secondary end points included tumor objective response rate (defined as the proportion of patients with complete or partial tumor response) and overall survival (defined as the time from the start of treatment to any cause of death). According to the protocol, all participants whose disease has progressed were to be followed up by clinic visit or telephone call every 3 months to assess survival until 36 months from the date that the last participant was randomized or death, whichever occurred earlier.…”

TAS-102 in metastatic colorectal cancer (mCRC): efficacy, tolerability, and quality of life in heavily pretreated elderly patients: a real-life study

“…In 2019, 24% of newly diagnosed CRC patients were aged >70 years 16 and 14% of CRC deaths are expected to occur in these patients in the coming years. 17 , 18 In elderly patients with mCRC, the goal of treatment includes the control of symptoms, maintaining good QoL, and increasing survival. Despite the rapid growth in the number of onco-geriatric patients, elderly cancer patients are underrepresented in clinical trials and the results of clinical trials in younger patients cannot be extrapolated to the treatment of the elderly.…”

PREMIUM: A French prospective multicenter observational study of factors impacting on efficacy and compliance to cetuximab treatment in first-line KRAS wild-type metastatic colorectal cancer

“…PFS was chosen as the primary endpoint based on the results of several published analyses, demonstrating that PFS can act as a surrogate for OS in the first-line treatment metastatic colorectal cancer [ 9 , 10 ]. PFS is often chosen over OS in clinical trials as OS is impacted by the outcomes of subsequent therapeutic lines and does not directly evaluate the benefit of a given therapy [ 11 ].…”

“…OS in the first-line treatment metastatic colorectal cancer [9,10]. PFS is often chosen over OS in clinical trials as OS is impacted by the outcomes of subsequent therapeutic lines and does not directly evaluate the benefit of a given therapy [11]. The median PFS (11.0 months) of mCRC patients receiving first-line cetuximab in PRE-MIUM is similar to that reported in randomized control trials as CRYSTAL, OPUS, COIN, TAILOR and FIRE-3 trials (9.9 months, 8.3 months, 8.6 months, 9.2 months and 10 months respectively) [4,7,[12][13][14], although it is slightly longer.…”