Combination L-Glutamine with Gemcitabine and Nab-Paclitaxel in Treatment-Naïve Advanced Pancreatic Cancer: The Phase I GlutaPanc Study Protocol
, Arsen Osipov 1, Jeremy Lorber 1, Mourad Tighiouart 2, Albert K. Kwan 1, Hayato Muranaka 1, Rasaq Akinsola 1, Sandrine Billet 1, Abrahm Levi 1, Anser Abbas 1, John Davelaar 1, Neil Bhowmick 1 and Andrew E. Hendifar 1
Round 1
Reviewer 1 Report
Advanced pancreatic cancer is underscored by progressive therapeutic resistance. Preclinical data demonstrated glutamine supplementation, not deprivation, elicited antitumor effects against pancreatic ductal adenocarcinoma (PDAC) alone and in combination with gemcitabine in a dose-dependent manner. The GlutaPanc study is investigating the safety of combination L-glutamine, gemcitabine, and nab-paclitaxel in patients (n=16) with treatment-naïve, unresectable or metastatic pancreatic cancer. Following a 7-day lead-in phase with L-glutamine, the dose-finding phase via Bayesian design begins with treatment cycles lasting 28 days until disease progression, intolerance, or withdrawal. The primary objective of the study is to determine the recommended phase II dose (RP2D) of combination L-glutamine, gemcitabine, and nab-paclitaxel. Secondary objectives include safety of the combination across all dose levels and preliminary evidence of antitumor activity. The manuscript is interesting and well written and I have minor comment mentioned further.
At the end of introduction part there is need to state what is the novelty of present research. What was done for the first time?
Author Response
We thank the reviewer for taking the time to review this manuscript. We have added a statement at the end of the Introduction highlighting the novelty of this study.
Reviewer 2 Report
This manuscript is a study protocol for a phase I trial of first-line L-glutamine with gemcitabine and nab-paclitaxel in advanced pancreatic cancer. Overall, the manuscript is very interesting and well-written. I only have a few minor observations:
1. There are some typos. The work would benefit from close editing.
2. Relocate the study objectives to the end of the introduction.
3. Rewrite the conclusion paragraph.
Author Response
We thank the reviewer for the time spent on reviewing this manuscript. We believe that the suggestions improve the strength of this manuscript. We have combed through the manuscript and made multiple corrections to typos and grammar mistakes throughout the manuscript. We have relocated the study objectives to the end of the Introduction, as suggested. We have rewritten and expanded the Conclusion paragraph, as recommended.
