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A phase 2 trial of radiation therapy with concurrent paclitaxel chemotherapy after surgery in patients with high-risk endometrial cancer: a Korean Gynecologic Oncologic Group study.

AbstractPURPOSE:
A phase 2 study was completed by the Korean Gynecologic Oncologic Group to evaluate the efficacy and toxicity of concurrent chemoradiation with weekly paclitaxel in patients with high-risk endometrial cancer.
METHODS AND MATERIALS:
Pathologic requirements included endometrial endometrioid adenocarcinoma stages III and IV. Radiation therapy consisted of a total dose of 4500 to 5040 cGy in 5 fractions per week for 6 weeks. Paclitaxel 60 mg/m(2) was administered once weekly for 5 weeks during radiation therapy.
RESULTS:
Fifty-seven patients were enrolled between January 2006 and March 2008. The median follow-up time was 60.0 months (95% confidence interval [CI], 51.0-58.2). All grade 3/4 toxicities were hematologic and usually self-limited. There was no life-threatening toxicity. The cumulative incidence of intrapelvic recurrence sites was 1.9% (1/52), and the cumulative incidence of extrapelvic recurrence sites was 34.6% (18/52). The estimated 5-year disease-free and overall survival rates were 63.5% (95% CI, 50.4-76.5) and 82.7% (95% CI, 72.4-92.9), respectively.
CONCLUSIONS:
Concurrent chemoradiation with weekly paclitaxel is well tolerated and seems to be effective for high-risk endometrioid endometrial cancers. This approach appears reasonable to be tested for efficacy in a prospective, randomized controlled study.
AuthorsHanbyoul Cho, Byung-Ho Nam, Seok Mo Kim, Chi-Heum Cho, Byoung Gie Kim, Hee-Sug Ryu, Soon Beom Kang, Jae-Hoon Kim
JournalInternational journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 90 Issue 1 Pg. 140-6 (Sep 01 2014) ISSN: 1879-355X [Electronic] United States
PMID25015202 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
CopyrightCopyright © 2014 Elsevier Inc. All rights reserved.
Chemical References
  • Antineoplastic Agents, Phytogenic
  • Radiation-Sensitizing Agents
  • Paclitaxel
Topics
  • Adult
  • Aged
  • Antineoplastic Agents, Phytogenic (adverse effects, therapeutic use)
  • Carcinoma, Endometrioid (mortality, pathology, secondary, therapy)
  • Chemoradiotherapy (adverse effects, methods)
  • Confidence Intervals
  • Disease-Free Survival
  • Dose Fractionation, Radiation
  • Endometrial Neoplasms (mortality, pathology, therapy)
  • Female
  • Humans
  • Middle Aged
  • Neoplasm Recurrence, Local (mortality, pathology)
  • Paclitaxel (adverse effects, therapeutic use)
  • Postoperative Care
  • Prospective Studies
  • Radiation-Sensitizing Agents (adverse effects, therapeutic use)
  • Republic of Korea
  • Survival Analysis

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