Preliminary results of RTOG 9703 - a phase II randomized trial of concurrent radiation (RT) and chemotherapy for advanced Squamous Cell Carcinomas (SCC) of the head and neck
University of Pennsylvania Cancer
Last Modified: May 13, 2001
Presenter: A.S. Garden
Affiliation: U.T.M.D. Anderson Cancer Center, Houston, TX
- Concurrent chemoradiation may improve Survival for advanced Head and Neck cancer. 2. Numerous studies have evaluated different treatment approaches with different fractionation, chemotherapeutic agents, and timing of drug administration.
- 241 patients (pts) entered on RTOG 97-03, 7/97 -6/99 .
- Eligibility criteria included histologic proof of SCC of the oral cavity,oropharynx or hypopharynx; stage III or IV, M0 disease; KPS 70%
- Pts were randomized to one of three arms: 70 Gy/7 weeks (wks) with cisplatin 10mg/m2 and 5-FU 400mg/m2 daily during the last 10 days (wk6-7) of therapy (XCF); 70 Gy/13 wks (therapy given on alternating wks) with daily hydroxyurea 1 gm BID and 5-FU 800mg/m2(FHX); or 70 Gy/ 7 wks with weekly paclitaxel 30mg/m2 (d1) and cisplatin 20 mg/m2 (d2)(XCT).
- Of the 1,227 pts that are evaluable; 77 were randomized to XCF, 74 to FHX and 76 to XCT.
- Grade 4 toxicities occurred as follows: XCF -25%, FHX - 32%, and XCT - 29%. Deaths within 100 days of randomization occurred in 5 pts on XCF, 3 pts on FHX and 4 pts on XCT; two deaths on the XCF arm were associated with neutropenic sepsis.
- Median follow-up for surviving pts was 1.6 years (range 0.01 - 2.8 years). Estimated 1- and 2-year survival rates were 72% and 60% for XCF, 87% and 65% for FHX, and 80% and 67% for XCT.
- Comparisons were made between pts treated on 97-03 and historical controls which showed a reduction in death rates from cancer.
- All 3 arams were with acceptable toxicity, though >/= 25% toxicity were
- These results suggest large reductions in death rates in pts treated on all 3 arms of 97-03 compared with historical controls (radiation alone or radiation and cisplatin.)
- Whenver comparing current study with historical controls, one needs to consider the differences in technical advancement, treatment approach and ancillary support.
- This area needs futher studies to better define the roles of chemotherapy and radiation when used in a concurrent approach.
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