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Jan 23, 2013

inicians may have another therapy option for the patients with difficult-to-treat advanced pancreatic cancer, according to an

ternational study to be presented later this week at the 2013 Gastrointestinal Cancers Symposium in San Francisco,alifornia.

he addition of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane, Celgene) to gemcitabine significantly improved overall

rvival in treatment-naive patients with metastatic pancreatic cancer, compared with gemcitabine alone.

pecifically, in the phase 3 Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) of 861 patients, overall survival was

bout 2 months better with the chemotherapy combination than with gemcitabine alone (median, 8.5 vs. 6.7 months; hazard

tio [HR], 0.72; P= .000015).

his is a major improvement.

While a 2-month improvement may seem modest, in the pancreatic cancer space, this is a major improvement," said

enneth Yu, MD, from the Memorial Sloan-Kettering Cancer Center in New York City, who was not involved in the study but

as asked to comment by Medscape Medical News.

he rate of 1-year survival was better with the chemotherapy combination than with gemcitabine alone (35% vs 22%; P=

002), as was the rate of 2-year survival (9% vs 4%; P= .02).

elgene will submit these data in an approval application for the indication of pancreatic cancer in both the United States and

urope during the first half of 2013, and in other countries later this year. Nab-paclitaxel is already marketed for use in

etastatic breast cancer.

nab-paclitaxel is approved in combination with gemcitabine, it will, in a way, maintain a kind of status quo in advanced

sease. That's because gemcitabine, alone or in combination with other agents, has been the "reference regimen" for

vanced pancreatic cancer for an extended period of time, according to the authors of a study comparing the combination of

fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) with gemcitabine (N Engl J Med. 2011;364:1817-1825).

hat study provided the best survival timeever reported in metastatic pancreatic cancer. Overall survival was better with

OLFIRINOX than with gemcitabine (11.1 vs 6.8 months; P< .0001).

number of factors influence which drug combination that clinicians will chose in the future.

he New York Timesreports that nab-paclitaxel therapy costs around $6000 to $8000 a month, which will likely be more

pensive than FOLFIRINOX.

owever, toxicity has been a concern with the 4-drug combination, and experts haveopenly expressed doubtthat

OLFIRINOX should become the international standard of care for metastatic pancreatic cancer because of its adverse

fects. Researchers have stated that FOLFIRINOX may be best used in patients younger than 76 years who have advanced

sease and a good performance status.

r. Yu agrees with this assessment. At Memorial Sloan-Kettering, "FOLFIRINOX remains the treatment of choice for our

ancreatic cancer patients who are relatively fit," he said. However, he acknowledged the need for "judicious adjustment inosing" with the regimen.

ost patients are less robust, he explained. In the many patients who are weakened by their cancer, the combination of

emcitabine plus nab-paclitaxel "is a new and effective treatment that we can offer," he said.

Nab-Paclitaxel Extends Life in Advanced Pancreatic Cancer

ick Mulcahy

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he overall survival benefit of the different regimens needs to be balanced with other considerations.

While the overall survival of patients treated with gemcitabine and nab-paclitaxel does not reach the level seen in patients

eated with FOLFIRINOX, the toxicity profile [of gemcitabine plus nab-paclitaxel] does seem better, with only modestly

creased levels of neutropenia and fatigue," said Dr. Yu.

PACT Study Details

the open-label MPACT, patients were randomly assigned to 1 of 2 regimens: nab-paclitaxel 125 mg/m followed by

emcitabine 1000 mg/m for 3 weeks, then a week of rest; or gemcitabine 1000 mg/m administered weekly for 7 weeks, then

week of rest, followed by cycles of weekly gemcitabine administration for 3 weeks and a week of rest.

he combination demonstrated a statistically significant improvement in key secondary end points, compared with

emcitabine alone.

hese improvements include a 31% reduction in the risk for progression or death with the chemotherapy combination,

mpared with gemcitabine alone (median progression-free survival, 5.5 vs 3.7 months; HR, 0.69; P= 0.000024), and a better

erall response rate (23% vs 7%). Median time to treatment failure was also significantly better with the chemotherapymbination (5.1 vs 3.6 months; HR, 0.70; P< 0.0001).

ccording to company press materials, there were more grade 3/4 treatment-related adverse events with nab-paclitaxel plus

emcitabine than with gemcitabine alone; the most common were neutropenia (38% vs 27%), fatigue (17% vs 7%), and

europathy (17% vs 1%). In the nab-paclitaxel plus gemcitabine group, median time to neuropathy improvement was 29 days.

here was no difference between the groups in serious life-threatening toxicity (4% in each group).

he past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is

oth deadly and incredibly difficult to treat," said Daniel Von Hoff, MD, lead author of MPACT, in a press statement. He is from

e University of Arizona College of Medicine in Tucson. "The fact that nab-paclitaxel plus gemcitabine demonstrated an

erall survival benefit, and also did so at 1 and 2 years, is a significant step forward in offering potential new hope for ouratients," he said.

he study was funded by Celgene.

013 Gastrointestinal Cancers Symposium (GICS): Abstract LBA 148. To be presented January 25, 2013.

edscape Medical News 2013 WebMD, LLC

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ite this article: Nab-Paclitaxel Extends Life in Advanced Pancreatic Cancer. Medscape. Jan 23, 2013.

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