Publication Year: 2001
Larynx Preservation Using Weekly Paclitaxel, Carboplatin and Concurrent Radiotherapy in Advanced Laryngeal and Hypopharyngeal Carcinoma.
M Memon, A Al Amro, M Rahal, N Al Rajhi, A Radwi, A El-Weshi, King Faisal Specialist Hospital & Research Center, Riyadh, Saudi Arabia.
From Feb/98 through Feb/2000, 17 patients (pts) with locally advanced squamous Cell carcinoma of larynx/hypopharynx have been treated with concomitant chemoradiation therapy. Chemotherapy: Weekly paclitaxel (40 mg/m2) with carboplatin (AUC=2) for a total of 6 cycles. Radiation: consisted of 66 Gy at 2 Gy/fraction/day over 6 weeks and half. Patients: M/F= 9/8; Age: 52 years (37-74); PS=1:12pts, 2:7pts. Primary site: larynx/hypopharynx: 7/10, T2/T3/T4 : 1/6/10, N0/N1/N2/N3 : 11/1/2/3; Stage III/IV: 6/11. 8pts were unresectable. At presentation 10 pts had tracheostomy and 5 pts required tube feeding. Results: 13pts completed 6 cycles of chemotherapy, 2pts: 5 cycles and 2pts: 3 cycles, for a total of 93 cycles, all given at full dose, only 2 were delayed. The hematologic toxicity was mild. 1 febrile neutropenia (after cycle 6). 9pts completed 66 Gy without interruption, 2pts with <7 days; and 3pts with more than 7 days delay. Grade III/IV mucocitis: 9pts, skin: 8pts. Weight loss: <5%: 6pts, 5-10%: 1pt, 10%: 4pts. 5pts were admitted for nutritional support. Soft tissue necrosis (around tracheotomy tube): 2pts. Evaluation: 8 weeks post radiation: CR=12 pts; residual/progression: 5pts. With a median follow-up of 19 months (10-34); 12pts are alive with no evidence of disease. 5pts have died (all initially unresectable T4 of hypopharynx.). All laryngeal carcinoma patients are alive with no evidence of disease. Conclusion: Concomitant paclitaxel, carboplatin and radiation therapy leads to high local control in locally advanced laryngeal/hypopharyngeal carcinoma with acceptable toxicity and hold great promise.
Publication Year: 2001
Phase III Trial to Preserve the Larynx: Induction Chemotherapy and Radiotherapy Versus Concomitant Chemoradiotherapy Versus Radiotherapy Alone, Intergroup Trial R91-11.
Arlene A. Forastiere et al.
From Aug 1992 to May 2000, 547 pts with stage III&IV potentially resectable cancer of the larynx were randomized to receive: Arm A-induction cisplatin 100 mg/m2 + 5-FU 1000mg/m2/day x 120 hrs(CF) for 3 cycles followed by RT in responding pts, Arm B- concurrent cisplatin(C) 100 mg/m2 days 1,22,43 and RT or Arm C- RT alone. RT total dose was 70 Gy in 7 wks, 2 Gy/fx for all three arms. Arm A served as the control; the primary endpoint was laryngectomy-free survival(LFS). Characteristics of 497 analyzable pts were: median age-59 yrs; KPS[greater than or equal to]80%- 94%; site: glottis- 32%, supraglottis-68%; T2/T3/T4 - 11%/79%/10%; N0-1/N2/N3 - 72%/26%/2%. Results: The 2-year LFS rates for the 3 treatments are: A-58%, B-66%, C-52%. There is no significant difference in LFS or overall survival comparing Arms B or C to control Arm A. Time to laryngectomy(TTL) is significantly better for Arm B compared to Arm A, p=.0094. Secondary analysis comparing Arm B to Arm C demonstrates a significant difference in LFS (p=.02) and TTL (p=.00035). Conclusion: No significant differences were found comparing induction CF+RT to RT alone. Concurrent C+RT significantly increases the TTL.