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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

Diana Stripp, MD

University of Pennsylvania Cancer
Last Modified: May 13, 2001

Presenter: A.S. Garden
Affiliation: U.T.M.D. Anderson Cancer Center, Houston, TX

Background:

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.

Materials and Methods:

1. 241 patients (pts) entered on RTOG 97-03, 7/97 -6/99 .
2. Eligibility criteria included histologic proof of SCC of the oral cavity,oropharynx or hypopharynx; stage III or IV, M0 disease; KPS 70%
3. 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).

Results:

• 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.

Authors' Conclusions

1. All 3 arams were with acceptable toxicity, though >/= 25% toxicity were
2. 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.)

Clinical/Scientific Implications:

1. Whenver comparing current study with historical controls, one needs to consider the differences in technical advancement, treatment approach and ancillary support.
2. This area needs futher studies to better define the roles of chemotherapy and radiation when used in a concurrent approach.