|The following article features coverage from the ESMO World Congress on Gastrointestinal Cancer 2018 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
The combination of nab-paclitaxel plus gemcitabine improved quality of life scores and increased time to deterioration compared with gemcitabine monotherapy in patients with pancreatic ductal adenocarcinoma (PDAC), according to results of a phase 2 trial presented at the ESMO World Congress on Gastrointestinal Cancer 2018.1
The addition of nab-paclitaxel to gemcitabine prolonged overall and progression-free survival and increased response rates compared with single-agent gemcitabine. This study evaluated the effect of the combination on quality of life.
The multicenter, phase 2 trial randomly assigned 146 patients with locally advanced or metastatic PDAC to receive 1000 mg/m2 of gemcitabine with or without 125 mg/m2 nab-paclitaxel. Cross-over to the combination was allowed at progression. The primary endpoint was deterioration-free rate and a clinically relevant deterioration was considered to be a 10-point decrease in global health status (GHS). Secondary endpoints included safety, overall survival (OS), progression-free survival (PFS), and response rate.
The median age at baseline was 65 years and 86% of patients had metastatic disease. The median duration of treatment was 5 months, and the total cumulative drug exposure to nab-paclitaxel was 73% of the planned dose. Overall, 25% of patients crossed over to receive the combination after progressing during monotherapy.
The combination prolonged time to deterioration, with a 3-month deterioration-free rate of 83% compared with 60% in the monotherapy group and 96% in the cross-over group. The median time to definitive deterioration was 12.8 months with the combination compared with 8.9 months and 12.3 months with gemcitabine monotherapy or after cross-over, respectively.
Tumor response occurred in 43% (95% CI, 31% – 55%) of patients who received nab-paclitaxel plus gemcitabine compared with 19% (95% CI, 6% – 32%) receiving monotherapy and 24% (95% CI, 10% – 39%) who crossed over to the combination.
PFS was similar among groups, with a median of 7.4, 7.2, and 5.4 in the combination, monotherapy, and cross-over groups, respectively. The overall median PFS was 6.8 months (95% CI, 0.7 – 28.1 months). The combined median OS was 11.9 months (95% CI, 10 – 14 months), and the median in the combination, monotherapy, and cross-over groups were 10.7, 8.8, and 13 months.
Adverse events occurred in 51% and 37% of patients in the combination and single-agent arms, respectively, with the most common including gastrointestinal toxicities or infections. There were 6 deaths, 1 of which was possibly related to treatment with gemcitabine.
The authors concluded that nab-paclitaxel plus gemcitabine improved quality of life for a longer period than single-agent gemcitabine. Additional quality-of-life analyses are ongoing.
Read more of Cancer Therapy Advisor‘s coverage of the ESMO World Congress on Gastrointestinal Cancer 2018 meeting by visiting the conference page.
- Chiritescu G, Dumon K, Verslype C, et al. Gemcitabine with nab-paclitaxel in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC): A quality of life randomized cross-over study (QOLINPAC) Ann Oncol. 2018;29 (suppl 5;abstr O-003):v101. doi:10.1093/annonc/mdy149