Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer - PubMed (original) (raw)
Clinical Trial
. 1999 Apr 15;340(15):1144-53.
doi: 10.1056/NEJM199904153401502.
Affiliations
- PMID: 10202165
- DOI: 10.1056/NEJM199904153401502
Free article
Clinical Trial
Concurrent cisplatin-based radiotherapy and chemotherapy for locally advanced cervical cancer
P G Rose et al. N Engl J Med. 1999.
Free article
Erratum in
- N Engl J Med 1999 Aug 26;341(9):708
Abstract
Background and methods: On behalf of the Gynecologic Oncology Group, we performed a randomized trial of radiotherapy in combination with three concurrent chemotherapy regimens -- cisplatin alone; cisplatin, fluorouracil, and hydroxyurea; and hydroxyurea alone -- in patients with locally advanced cervical cancer. Women with primary untreated invasive squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix of stage IIB, III, or IVA, without involvement of the para-aortic lymph nodes, were enrolled. The patients had to have a leukocyte count of at least 3000 per cubic millimeter, a platelet count of at least 100,000 per cubic millimeter, a serum creatinine level no higher than 2 mg per deciliter (177 micromol per liter), and adequate hepatic function. All patients received external-beam radiotherapy according to a strict protocol. Patients were randomly assigned to receive one of three chemotherapy regimens: 40 mg of cisplatin per square meter of body-surface area per week for six weeks (group 1); 50 mg of cisplatin per square meter on days 1 and 29, followed by 4 g of fluorouracil per square meter given as a 96-hour infusion on days 1 and 29, and 2 g of oral hydroxyurea per square meter twice weekly for six weeks (group 2); or 3 g of oral hydroxyurea per square meter twice weekly for six weeks (group 3).
Results: The analysis included 526 women. The median duration of follow-up was 35 months. Both groups that received cisplatin had a higher rate of progression-free survival than the group that received hydroxyurea alone (P<0.001 for both comparisons). The relative risks of progression of disease or death were 0.57 (95 percent confidence interval, 0.42 to 0.78) in group 1 and 0.55 (95 percent confidence interval, 0.40 to 0.75) in group 2, as compared with group 3. The overall survival rate was significantly higher in groups 1 and 2 than in group 3, with relative risks of death of 0.61 (95 percent confidence interval, 0.44 to 0.85) and 0.58 (95 percent confidence interval, 0.41 to 0.81), respectively.
Conclusions: Regimens of radiotherapy and chemotherapy that contain cisplatin improve the rates of survival and progression-free survival among women with locally advanced cervical cancer.
Comment in
- Improved treatment for cervical cancer--concurrent chemotherapy and radiotherapy.
Thomas GM. Thomas GM. N Engl J Med. 1999 Apr 15;340(15):1198-200. doi: 10.1056/NEJM199904153401509. N Engl J Med. 1999. PMID: 10202172 No abstract available. - Treatment of high-risk cervical cancer.
Pearcey RG, Mohamed IG, Hanson J. Pearcey RG, et al. N Engl J Med. 1999 Aug 26;341(9):695-6; author reply 696-7. doi: 10.1056/NEJM199908263410913. N Engl J Med. 1999. PMID: 10475822 No abstract available. - Treatment of high-risk cervical cancer.
Piver MS. Piver MS. N Engl J Med. 1999 Aug 26;341(9):696-7. N Engl J Med. 1999. PMID: 10475823 No abstract available.
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