Intraperitoneal Chemotherapy for Ovarian Cancer: The QOL Trade-Off
Intraperitoneal Chemotherapy for Ovarian Cancer: The QOL Trade-Off
By William B. Ershler, MD, Editor, INOVA Fairfax Hospital Cancer Center, Fairfax, VA; Director, Institute for Advanced Studies in Aging, Washington, DC.
Abstract & Commentary
Synopsis: Recent advances in ovarian cancer management include the demonstration of improved progression-free and overall survival with intraperitoneal (IP) chemotherapy in the adjuvant setting. For example, the Gynecologic Oncology Group (GOG) has reported an increase by 15.9 months in IP vs standard dose intravenous (IV) chemotherapy for good performance status in stage III patients after debulking. However, the added months come at significant impingement in quality of life, as apparent in the GOG trial and detailed in this report.
Source: Wenzel LB, et al. Health-related quality of life during and after intraperitoneal versus intravenous chemotherapy for optimally debulked ovarian cancer: A Gynecologic Oncology Group study. J Clin Oncol. 2007;25:437-443.
There have now been three randomized trials demonstrating superior survival with intraperitoneal (IP) vs intravenous (IV) cisplatin for adjuvant treatment after successful debulking of ovarian cancer.1-3 The Gynecologic Oncology Group (GOG) recently reported their phase III trial in which patients were randomly assigned to receive either IV paclitaxel plus cisplatin or IV paclitaxel plus IP cisplatin. The improvement in median overall survival was 15.9 months for the IP treated patients, but this was associated with a greater infringement on quality of life (QOL). The current report details the QOL results from this trial.
Patients (n = 415) with stage III ovarian cancer or primary peritoneal carcinoma who had no residual disease greater than 1 cm in diameter and met other eligibility criteria were enrolled onto GOG 172 and received paclitaxel 135 mg/m2 IV over 24 hours followed by either cisplatin 75 mg/m2 IV on day 2 (IV arm) or cisplatin 100 mg/m2 IP on day 2 plus paclitaxel 60 mg/m2 IP on day 8 (IP arm). Treatment cycles were every 3 weeks for a total of 6 cycles.
QOL, neurotoxicity, and abdominal discomfort were assessed by questionnaires administered on four occasions; before randomization, before chemotherapy cycle 4, approximately one month after treatment, and one year after completion of treatment. For QOL, Functional Assessment of Cancer Therapy (FACT)-Trial Outcome Index (which includes physical, functional, and ovarian subscales) was utilized. Neurotoxicity was assessed by FACT/GOG-Ntx, which is an 11 item scale used to assess short- and long-term symptoms of neurotoxicity. Symptoms of abdominal discomfort were captured by two additional questions added to the above instruments specifically for this study.
Physical and functional well being and ovarian cancer symptoms were significantly worse in the IP arm before cycle 4 (P < 0.001) and at one month after treatment (P < 0.001). Patients in the IP arm also reported significantly worse abdominal discomfort before cycle 4 (P < 0.001) and significantly worse symptoms of neurotoxicity at one month and twelve months after completion of treatment. There was evidence that QOL in general improved over time in both groups upon completion of therapy.
Commentary
For women with optimally debulked ovarian cancer and good performance status, recent data indicates a significantly improved progression-free and overall survival with the more intensive IP drug administration. However, the more intensive regimens carry increased toxicity and associated negative impact on quality of life. It would seem the findings are consequential, as 98 patients in the IP arm vs only 30 patients in the IV arm had dropped off study by cycle 4.
A 15.9 month survival advantage is not inconsequential either, and, at the moment, the precise role for IP treatment as the initial post surgical adjuvant approach remains controversial. And, as usual, the practicing oncologist finds him/herself in the middle, weighing the latest advances measured in added months of life against those more subjective but equally important factors that influence the QOL in those remaining months. Hopefully the GOG and/or other groups will focus future studies on reducing toxicity and improving QOL while not slipping back on those added months of life for those with ovarian cancer.
References
1. Markman M, et al. J Clin Oncol. 2001;19:1001-1007.
2. Alberts D, et al. N Engl J Med. 1996;335:1950-1955.
3. Armstrong D, et al. N Engl J Med. 2006;354:34-43.
Recent advances in ovarian cancer management include the demonstration of improved progression-free and overall survival with intraperitoneal (IP) chemotherapy in the adjuvant setting.Subscribe Now for Access
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