Safety and Efficacy of Modified FOLFOX6 for Treatment of Metastatic or Locally Advanced Colorectal Cancer

Abstract

Background: Although a variety of FOLFOX regimens (5-fluorouracil and L-leucovorin combined with oxaliplatin) are widely used for the treatment of advanced colorectal cancer, the neurotoxicity caused by oxaliplatin is often problematic. The aim of this observational study was to assess the safety and efficacy of a modified version of the FOLFOX6 regimen (mFOLFOX6) when administered using the ‘stop-and-go’ strategy. Patients and Methods: A total of 112 eligible patients treated between June 2005 and July 2007 were identified using the prospective cohort database system of Kyoto University Hospital. Results: The median follow-up was 16.3 months (range 1.6–33.9), and the response rate was 33.3% (95% CI 14.5–52.2), 40.0% (95% CI 22.5–57.5) and 14.0% (95% CI 3.6–24.3) for patients who received mFOLFOX6 as first-line therapy, second-line therapy and third- or later-line therapy, respectively. The estimated median progression-free survival was 8.7 months (95% CI 2.3–15.1) and 8.2 months (95% CI 7.3–9.1) for patients on first-line and second-line therapy, respectively. The median overall survival was not reached as of April 2008 for the patients on first-line therapy, while it was 27.1 months (95% CI 22.0–32.2) for those on second-line therapy. Severe neurotoxicity occurred in only 4 patients (3.6%). Conclusion: mFOLFOX6 administered using the stop-and-go strategy significantly reduced oxaliplatin-induced neurotoxicity relative to conventional FOLFOX treatment, without compromising efficacy.

Oxaliplatin-Free Interval as a Risk Factor for Hypersensitivity Reaction among Colorectal Cancer Patients Treated with FOLFOX

“…Patients were identified by searching the prospective cohort database of the Outpatient Oncology Unit [6]. The following clinical data were extracted from the database and the electronic medical chart system: basic demographic data, site of the primary tumor (colon or rectum), disease stage according to the AJCC Cancer Staging Manual (6th edition), presence or absence of liver and lung metastases, history of allergic diseases such as asthma and atopic diseases, history of allergies to drugs or food, previous chemotherapy, prior exposure to other platinum agents, total number of cycles of FOLFOX received, and cumulative dose of oxaliplatin received.…”

“…The stop-and-go strategy has been shown to yield clinical efficacy comparable to that of conventional continuous treatment, but with a lower incidence of sensory neuropathy [5]. Given the evidence for its efficacy, at the Kyoto University Hospital we have used the stop-and-go strategy with the modified FOLFOX6 (mFOLFOX6) regimen since July 2006 [6]. …”

Reintroduction of Oxaliplatin: A Viable Approach to the Long-Term Management of Metastatic Colorectal Cancer

“…The concept of treatment holidays fits well with current strategies for managing peripheral neuropathy. The stop-and-go strategy has been advocated [16,20] and evaluated in a number of recent clinical trials (table 2) [13,21,22,23,24,25]. Data from these trials suggest that patients receiving oxaliplatin through a stop-and-go approach can expect at least comparable clinical outcomes [24,26] to those achieved by patients receiving continuous delivery of oxaliplatin, but with significantly reduced neurotoxicity and overall toxicity [13,22,23,24,26].…”

“…Two studies provide confirmation that a stop-and-go approach can reduce oxaliplatin-associated neurotoxicity without compromising efficacy [22,23]. The results of one of these studies, which was designed to evaluate the efficacy of a modified version of the FOLFOX6 regimen delivered using a stop-and-go approach, were recently reported [22].…”

“…The results of one of these studies, which was designed to evaluate the efficacy of a modified version of the FOLFOX6 regimen delivered using a stop-and-go approach, were recently reported [22]. A total of 112 patients with locally advanced or mCRC took part and were followed up for a mean of 16.3 months.…”