A pilot study of high-dose intraarterial cisplatin chemotherapy with concomitant accelerated radiotherapy for patients with previously untreated T4 and selected patients with T3N0-N3M0 squamous cell carcinoma of the upper aerodigestive tract.
BACKGROUND
This Phase I clinical trial was developed to assess the feasibility of combining high-dose intraarterial cisplatin chemotherapy with concurrent, concomitant boost accelerated radiation therapy for patients with previously untreated T4 and select patients with T3N0-N3M0 squamous cell carcinoma of the upper aerodigestive tract.


METHODS
Between July 1999, and February 2002, 19 patients were treated with 3 or 4 weekly cycles of intraarterial Cisplatin chemotherapy (150 mg/m(2)) with concurrent, concomitant boost accelerated radiation therapy (72 grays in 42 fractions over 6 weeks).


RESULTS
Two patient deaths occurred among the first 15 patients enrolled. Both patients presented with febrile neutropenia, and both died of complications related to infection. The number of cycles of intraarterial cisplatin was reduced from four cycles to three cycles, and an additional four patients were treated. The fourth patient treated on the modified protocol developed febrile neutropenia, sepsis, and a thromboembolic event, which resulted in lower extremity amputations. The maximum acute toxicity experienced was Grade 2 in 6 patients, Grade 3 in 5 patients, Grade 4 in 6 patients, and Grade 5 in 2 patients. With a median follow-up of 21 months (range, 6.2-34.6 months), the overall survival at 1 year was 89.5% (95% confidence interval [95%CI], 76.7-100%). At 1 year, 92.9% of the patients were free from disease progression (95%CI, 80.3-100%).


CONCLUSIONS
The results of this study suggest that concurrent intraarterial cisplatin chemotherapy at a dose of 150 mg/m(2) with concomitant boost accelerated radiation therapy is not feasible.
Foote
Robert L
RL
Division of Radiation Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA.
Kasperbauer
Jan L
JL
Okuno
Scott H
SH
Nichols
Douglas A
DA
Olsen
Kerry D
KD
Brown
Paul D
PD
Garces
Yolanda I
YI
Sargent
Daniel J
DJ
Strome
Scott E
SE
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000556:secondary; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage*; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D006801:Humans; D007261:Infusions, Intra-Arterial; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D016019:Survival Analysis; D016896:Treatment Outcome
D000970:Antineoplastic Agents; D002945:Cisplatin