Cancer Science & Therapy

Duration of Chemotherapies in Phase III Studies on Metastatic Colorectal Cancer Treated With a Continuous Approach: A Seven-Year Survey

Abstract

Alessandro Ottaiano, Maurizio Capuozzo, Guglielmo Nasti, Anna Nappi, Chiara De Divitiis, Monica Capozzi, Salvatore Tafuto, Piera Maiolino and Vincenzo Rosario Iaffaioli

In last years, many phase III studies have addressed the role of chemotherapy or chemo/biotherapy in metastatic colorectal cancer (mCRC); most of these studies planned their treatment to be continued until disease progression or intolerable toxicity with the aim to obtain a long-term control of the cancer. However, the real duration of this approach might be significantly lower than planned. We made a survey to describe the real duration of chemotherapy in published phase III trials from January 2008 to December 2014. Twenty relevant publications were selected for a total of 48 treatment arms and of 24.475 patients. Median duration of chemotherapy in first-line studies ranged from 4,8 to 7,8 months; in second line from 2,4 to 5,2 months. Most common reasons of discontinuation were: progressive disease (PD), adverse events (AE) and patient request (PR). From 11.0% to 45.0% of patients discontinue treatment for toxicity or their request independently from the efficacy. PR was the third cause ranging from 4,6% to 26,0% of patients; in some studies, it overcame the AE-related withdrawals. Causes of PR for therapy discontinuation should be explored and analyzed to reduce the proportion of withdrawals in phase III studies.