Modified gemcitabine and nab-paclitaxel in patients with metastatic pancreatic cancer (MPC): A single-institution experience.

Abstract

366 Background: The combination of gemcitabine and nab-paclitaxel (GA) in first line treatment (tx) of MPC has a modest survival advantage over gemcitabine (gem) alone, but adds significant toxicities (tox) and increased cost. Based on data suggesting that biweekly administration (adm) of gem-based combinations preserves efficacy and improves tox profile, our institution adopted a modified regimen of GA (mGA). Methods: This is a retrospective analysis of a prospectively maintained database of patients (pts) with pancreatic cancer treated with gem (1000 mg/m2) and nab-paclitaxel (125 mg/m2) on days 1 and 15 of a 28-day cycle. Survival curves were estimated using Kaplan-Meier method, with alive pts censored at time of last follow-up. Cost of tx includes cost of drugs, adm, and tox. Results: Of total 69 pts treated with mGA for MPC, locally advanced, or borderline resectable disease, 63 pts were evaluable for tox (table 1). A total of 49 pts (47 evaluable for response) received mGA for previously untreated MPC, with median progression free survival of 4.8 months(mo) (95% CI 2.6,7.4) and overall survival of 11.1 mo (95% CI 5.3,not reached). Overall, 27% of pts experienced neurotoxicity with rate of grade 3 tox of < 2%, and 8% required growth factors (GF). Average cost savings was $5500/pt/month with mGA compared to standard GA, excluding GF cost which was lower with mGA. Conclusions: A less intense regimen of GA maintains efficacy while significantly improving tox profile and cost in pts with MPC. [Table: see text]

A phase 1b study of erlotinib in combination with gemcitabine and nab-paclitaxel in patients with previously untreated advanced pancreatic cancer: an Academic Oncology GI Cancer Consortium study

“…However, the toxicities of gemcitabine and nab-paclitaxel themselves as well as overlapping toxicities from new agents will present a challenge. In fact, recent data suggest that modifications of the gemcitabine/ nab-paclitaxel combination are commonly used in practice and result in similar efficacy [7]. This may open up additional opportunities for future clinical trial designs.…”

Cost description of chemotherapy regimens for the treatment of metastatic pancreas cancer

“…Gemcitabine/nab-paclitaxel is usually administered on days 1, 8 and 15 every 4 weeks [5]. Krishna et al [9] retrospectively evaluated a series of 49 patients who received treatment on days 1 and 15 every 4 weeks. We reported a median overall survival of 10 months, with lower rates of AEs than those observed in the standard regimen and thus reduced costs by almost half to $36, 266 (Table 1).…”

“…Schedule modification of nab-paclitaxel certainly offers a cost saving when the day 8 dose is omitted, while appearing to maintain a similar level of efficacy, although these data are based on a retrospective review [9]. This Total cost of care was obtained by multiplying median PFS by total monthly cost.…”

“…Gemcitabine/erlotinib costs were based on the following doses [6]: gemcitabine 1000 mg/m 2 on days 1, 8 and 15 of a 4-week cycle; erlotinib 100 mg daily. Dose-modified gemcitabine/nab-paclitaxel costs were based on the following doses [9]: gemcitabine 1000 mg/m 2 and nab-paclitaxel 125 mg/m 2 on days 1 and 15 of a 4-week cycle. We used a body surface area of 1.86 m 2 based on mean US values [10,11].…”

Nab-paclitaxel plus gemcitabine in the treatment of metastatic pancreatic cancer: utility and experience from the clinic

“…24 A prospective singlearm Phase II study was terminated early without published results (ClinicalTrials.gov identifier: NCT01851174). Dose modifications of the standard dosing are very pertinent in elderly patients, patients with liver dysfunction, or patients who may be receiving gemcitabine + nab-paclitaxel in a second-line setting (after being already exposed to FOL-FIRINOX).…”