Starting DD on CTIC competitor APPX. Reasonably good data to date on its nanoparticle formulation of taxol, however some intersting SEs that I don't believe usually show up in other taxol patients (ocular toxicity?):
>>Cancer 2001 Nov 15;92(10):2592-602
Intraarterial chemotherapy with polyoxyethylated castor oil free paclitaxel, incorporated in albumin nanoparticles (ABI-007): Phase II study of patients with squamous cell carcinoma of the head and neck and anal canal: preliminary evidence of clinical activity.
Damascelli B, Cantu G, Mattavelli F, Tamplenizza P, Bidoli P, Leo E, Dosio F, Cerrotta AM, Di Tolla G, Frigerio LF, Garbagnati F, Lanocita R, Marchiano A, Patelli G, Spreafico C, Ticha V, Vespro V, Zunino F.
Department of Radiology, Istituto Nazionale Tumori, Milano, Italy. damascelli@istitutotumori.mi.it
BACKGROUND: This study was designed to determine the feasibility, maximum tolerated dose, and toxicities of intraarterial administration of paclitaxel-albumin nanoparticles in patients with advanced head and neck and recurrent anal canal squamous cell carcinoma. Antitumor activity also was assessed. METHODS: Forty-three patients (31 with advanced head and neck and 12 with recurrent anal canal squamous cell carcinoma) were treated intraarterially with ABI-007 every 4 weeks for 3 cycles. In total, 120 treatment cycles were completed, 86 in patients with head and neck carcinoma (median, 3 cycles; range, 1-4) and 34 in patients with anal canal carcinoma (median, 3 cycles; range, 1-4). ABI-007 was compared preliminarily with Taxol for in vitro cytostatic activity. Increasing dose levels from 120 to 300 mg/m2 were studied in 18 patients. Pharmacokinetic profiles after intraarterial administration were obtained in a restricted number of patients. RESULTS: The dose-limiting toxicity of ABI-007 was myelosuppression consisting of Grade 4 neutropenia in 3 patients. Nonhematologic toxicities included total alopecia (30 patients), gastrointestinal toxicity (3 patients, Grade 2), skin toxicity (5 patients, Grade 2), neurologic toxicity (4 patients, Grade 2) ocular toxicity (1 patient, Grade 2), flu-like syndrome (7 patients, Grade 2; 1 patient, Grade 3). In total, 120 transfemoral, percutaneous catheterization procedure-related complications occurred only during catheterization of the neck vessels in 3 patients (2 TIA, 1 hemiparesis) and resolved spontaneously. CONCLUSIONS: Intraarterial administration of ABI-007 by percutaneous catheterization does not require premedication, is easy and reproducible, and has acceptable toxicity. The maximum tolerated dose in a single administration was 270 mg/m2. Most dose levels showed considerable antitumor activity (42 assessable patients with 80.9% complete response and partial response). The recommended Phase II dose is 230 mg/m2 every 3 weeks. Copyright 2001 American Cancer Society.<<
Further, it is my understanding that their PIII trial is underpowered, and does not use survival as endpoint. Have heard management has questionable ethical track record.
Help appreciated, but will start digging on my own. Into the WatchList with it. I might stop myself out of CTIC and switch horses if the APPX short looks good. Wilder, I believe you looked at this once?
Cheers, Tuck |
