New Chemotherapy Strategy Emerges in Ovarian Cancer

Anita T. Shaffer @Shaffer1
Published: Monday, Sep 24, 2012
Dr. Jonathan S. Berek

Jonathan S. Berek, MD, MMS
Professor and Director, Women’s Cancer Center, Stanford Cancer Institute, Stanford University School of Medicine, Stanford, CA

A study evaluating first-line chemotherapy dosing strategies for treating patients with advanced epithelial ovarian cancer has delivered practice-changing findings, and ongoing trials are likely to provide further clarity on the comparative benefits of routes of administration, according to Jonathan S. Berek, MD, MMS.

The noteworthy results stem from Japanese Gynecologic Oncology Group (JGOG) trial 3016, which established a significant survival benefit for patients who received dose-dense weekly paclitaxel plus carboplatin versus the conventional dosing schedule for those two drugs.1

“It’s a very important study,” said Berek, professor and director, Stanford Women’s Cancer Center at Stanford Cancer Institute in California, in an interview. “This trial demonstrates, at least within the context of this large, well-performed, prospective randomized trial, that the dose-dense (every week) intravenous chemotherapy regimen is preferable to the standard (every 3 weeks) intravenous regimen. Therefore, it is, as we say, a game-changer.”

Berek, who served as the discussant of the JGOG 3016 trial results at the American Society of Clinical Oncology (ASCO) annual meeting in June, said there are at least four prospective trials under way worldwide that should shed further light on whether the chemotherapy regimen is best delivered through intravenous (IV) or intraperitoneal (IP) administration.

Lead investigator Noriyuki Katsumata, MD, PhD, of the Department of Medical Oncology at the Nippon Medical School, Musashikosugi Hospital, Kawasaki, Japan, presented the JGOG 3016 follow-up data at ASCO. (The trial also is known as the NOVEL study).

The long-term results involve the experiences of 631 patients with stage II–IV epithelial ovarian, fallopian tube, or primary peritoneal cancers.

Participants were randomized to receive either the dose-dense regimen of carboplatin AUC 6.0 on day 1 and paclitaxel 80 mg/m2 on days 1, 8, and 15 versus the standard regimen of carboplatin AUC 6.0 and paclitaxel 180 mg/m2 on day 1. Treatments were repeated every 21 days for six cycles, with patients who responded eligible for three additional cycles.

After 6.4 years’ follow-up, the 312 patients who received dose-dense therapy achieved a median progression-free survival (PFS) of 28.2 months versus a median PFS of 17.5 months for the 319 patients who received the standard regimen (HR = 0.76, 95% CI [0.62-0.91]; P = .0037).

The median overall survival (OS) had not yet been reached in the dose-dense group, while the OS among those treated conventionally was 62.2 months. At five years, the survival rate was 58.7% in the dose-dense group, compared with 51.1% in the standard-treatment group (HR = 0.79, 95% CI [0.63-0.99]; P = .039).

Key Statistics in JGOG 3016 Trial, at 6.4 Years’ Follow-Up1

Treatment Patients (No) Median PFS Median OS
Dose-Dense 312 28.2 mo Not reached
Conventional 319 17.5 mo 62.2 mo
P value   .0037 .039

PFS indicates progression-free survival; OS, overall survival.

A subgroup analysis indicated that patients with clear-cell and mucinous carcinomas, who made up 15% to 17% of patients, did not show a statistically significant advantage with either treatment strategy. More than 80% of the patients in each arm had serous adenocarcinomas and other types.

“Neither dose-dense nor conventional treatment seemed effective against clear-cell or mucinous ovarian cancers, which suggests that other treatment strategies are needed,” Katsumata said in his presentation.

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