International trial shows better option for treating people with inoperable anal cancer

Clinical Trials & Research

People with inoperable anal cancer treated with carboplatin-paclitaxel had fewer complications and lived longer than those who received another chemotherapy that has been more often administered.

The results from an international trial, published by the Journal of Clinical Oncology, suggest that carboplatin-paclitaxel become the standard of care for anal cancer, a rare disease that accounts for less than 3% of all gastrointestinal malignancies. The InterAAct trial compared carboplatin-paclitaxel with cisplatin plus 5-flourouracil (5FU).

The InterAAct trial identifies carboplatin-paclitaxel as the optimal chemotherapy regimen in the first-line setting for inoperable anal cancer. Carboplatin-paclitaxel was associated with less toxicity and a trend toward improved survival, which suggests that it should become the standard of care for these patients and the backbone for future phase three trials.”

Cathy Eng, MD, lead U.S. investigator, David H. Johnson Chair in Surgical and Medical Oncology at Vanderbilt University and co-leader of the Gastrointestinal Cancer Research Program at Vanderbilt-Ingram Cancer Center

The overall survival of patients enrolled on the carboplatin-paclitaxel arm of the clinical trial was 20 months compared to 12.3 months for those on the cisplatin-5FU arm. Carboplatin-paclitaxel was associated with significantly less adverse effects (36%) compared to cisplatin-5FU (62%).

The study enrolled 91 patients from the United States, Australia, Germany, Norway and the United Kingdom between December 2013 and November 2017. The International Rare Cancers Initiative formed the Anal Cancer Working Group to design and conduct trials with the goal of providing metastatic anal cancer patients with new treatment strategies.

Patients with inoperable anal cancer have a five-year survival rate of approximately 30%.

Paclitaxel was first documented as a treatment for advanced anal cancer in 2011 and was later combined with carboplatin. Response rates of 69% had led some clinicians to administer it as a first-line treatment, but the cisplatin-5FU regimen had been adopted internationally.

The International Rare Cancers Initiative Anal Cancer Working Group, the National Cancer Institute and ECOG-ACRIN Cancer Research Group initiated the clinical trial comparing the two chemotherapies to provide clinician and clinical researchers better guidance about future clinical trial development.

Journal reference:

Rao, S., et al. (2020) International Rare Cancers Initiative Multicenter Randomized Phase II Trial of Cisplatin and Fluorouracil Versus Carboplatin and Paclitaxel in Advanced Anal Cancer: InterAAct. Journal of Clinical Oncology. doi.org/10.1200/JCO.19.03266.

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