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AlteRCC phase I-II trial: Alternating radiotherapy and chemotherapy plus cetuximab in advanced head and neck cancer (HNC).

15515 Background: Pfister (ASCO 2003) added Cetuximab (C) to CT/RT to evaluate toxicity and activity of this combination in advanced HNC. The trial was early stopped due to an excess of toxicity including on treatment deaths. However, the treated pts achieved an excellent long term.


RESULTS
76% of them were alive and disease free at 24 months. Therefore, a new, less toxic scheduling of CT/RT and C is highly attractive. Alternating CT/RT (ACR) may be less toxic than concurrent CT/RT (Haffty 2000; Merlano 2003). Therefore we designed a phase I-II trial, scheduling finding, combining ACR and C.


METHODS
The ACR regimen consists of cisplatin 20 mg/m2 and 5FU 200 mg/m2 days 1 to 5, weeks 1, 4 and 7; and RT, 2 Gy/day, days 1 to 5, weeks 2-3, 5-6, 8-10 to a total dose of 66 Gy. ACR remains unchanged during both phase I and phase II part of the study, whereas C is given to the first 6 pts (phase I, step I) weekly only in the weeks when RT is delivered. If no limiting toxicity is observed, C is combined also with CT, in a second group of six pts (phase I step II). If again no limiting toxicity is recorded, the trial will be continued as a phase II study (optimal two-stage design, 21+24 pts, Simon 1989).


RESULTS
At the time of the present report, the phase I step I is completed and 3 pts in phase I step II are on-going. All the pts had HNC stage IVa (8 pts) or stage III (1 pt). Two pts had disease recurrence after prior surgery, while the others had previously untreated cancers. All the tumors over-expressed EGFr (+++), but the percentage of cells expressing EGFr ranges between 10 to 100% (median 70%), One episode of neutropenic fever occurred in one pt enrolled in phase I step II. All the pts developed chemoradiation expected toxicities, including stomatitis and dysphagia requiring TPN. The only unexpected toxicity was a moist desquamation occurring within the irradiated field which was observed in all but one pts at a cumulative RT dose of 50-66 Gy. This toxicity did not interfere with ACR treatment but C was stopped until recovery. Recovery occurred in 5-7 days. Four pts out of the 6 evaluable for response, reached a complete response; the two remaining achieved a PR. One of them underwent surgical removal of a residual nodal mass without complications.


CONCLUSIONS
The update of the AlteRCC trial will be presented. [Table: see text].