Less-intensive regimen maintained efficacy, reduced toxicity in metastatic pancreatic cancer

A less-intensive first-line treatment regimen for patients with metastatic pancreatic cancer may decrease toxicity and reduce costs while maintaining efficacy, according to data from a single-institution study presented at the Gastrointestinal Cancers Symposium.

The combination of gemcitabine (Gemzar, Lilly) and nab-paclitaxel (Abraxane, Abraxis BioScience) is FDA approved for the treatment of metastatic pancreatic cancer.

A study by Von Hoff and colleagues, published in 2013 in The New England Journal of Medicine, determined a regimen of gemcitabine 1,000 mg/m² and nab-paclitaxel 125 mg/m² administered on days 1, 8 and 15 of each 28-day cycle significantly improved OS, PFS and response rate compared with gemcitabine monotherapy in patients with metastatic prostate cancer. However, the combination regimen was associated with increased rates of peripheral neuropathy and myelosuppression.

Tanios Bekaii-Saab

Prior research indicated biweekly administration of gemcitabine-based combinations reduced toxicity while maintaining efficacy. Based on those observations, clinicians at The Ohio State University Comprehensive Cancer Center — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute began using a modified regimen of gemcitabine and nab-paclitaxel as first-line treatment for patients with metastatic pancreatic cancer.

In the modified regimen, patients received gemcitabine and nab-paclitaxel in the same doses but only on days 1 and 15 of each 28-day cycle.

Kavya Krishna, MD, a hematology and oncology fellow at The Ohio State University Comprehensive Cancer Center, and colleagues retrospectively analyzed outcomes of 69 patients treated with the modified regimen.

Of these patients, 49 had treatment-naive metastatic pancreatic cancer. The other 20 had locally advanced or resectable disease or had already failed other chemotherapy options.

Median PFS was 4.8 months (95% CI, 2.6-7.4) and median OS was 11.1 months (95% CI, 5.3-not reached). OS with the modified regimen was comparable to the 8.5-month median OS observed in among patients assigned the more intensive gemcitabine and nab-paclitaxel regimen in the study by Von Hoff and colleagues.

Growth factor injections to boost production of white blood cells were required the day after chemotherapy in 8% of patients treated with the modified regimen vs. 26% of patients who received the more intensive regimen in the Von Hoff study.

Krishna and colleagues reported 27% of patients in their study experienced some level of toxicity, including anemia (15%), neutropenia (10%), fatigue (6%), thrombocytopenia (4%) and grade ≥3 neuropathy (2%).

Fewer than 2% of patients experienced severe neurological toxicities with the modified regimen, compared with 17% of patients treated with the more intensive regimen in the study by Von Hoff and colleagues.

Additionally, the modified regimen provided an average cost savings of $5,500 per patient per month, Krishna and colleagues reported.

“Shifting this treatment to every other week gives the immune system time to recover between chemotherapy sessions and results in less overall toxicity,” Tanios Bekaii-Saab, MD, associate professor and gastrointestinal oncology section chief at The Ohio State University Comprehensive Cancer Center, said in a press release. “It also means fewer visits to the infusion center to receive chemotherapy. This less-intensive, every-other-week treatment approach seems to be effective in treating our patients with metastatic pancreatic cancer while significantly reducing side effects that impact quality of life.”

For more information:

Krishna K. Abstract #366. Presented at: 2015 Gastrointestinal Cancers Symposium; Jan. 15-17, 2015; San Francisco.

Von Hoff DD. N Engl J Med. 2013;doi:10.1056/NEJMoa1304369.

Disclosure: The researchers report consultant/advisory roles with, honoraria from, research funding from, or other financial relationships with Amgen, AstraZeneca, Bayer, Biothera, Bristol-Myers Squibb, Celgene, Eli Lilly, Exelixis, Helsinn Therapeutics, Immunomedix, Merck, Oncolytics Biotech, Polaris, Regeneron and Sanofi-Aventis.