Fixed infusion rate (FIR) gemcitabine (G) based treatment for advanced renal cell carcinoma (ARCC): Efficacy and toxicity data from a phase II study

14632 Background: ARCC is still an untreatable disease because high dose IL2 therapy is feasible and effective only in a small percentage of patients (pts). Standard dose IL2 is palliative as well as every other treatment. G is a well tolerated agent, even in aged pts and is moderately effective in ARCC. FIR of 10 mg/m2/min increases intracellular G active metabolites and may enhance therapeutic and toxic effect. Aim of study was to evaluate the FIR-G effectiveness in ARCC. Methods: G was administered IV at 10 mg/m2/min FIR for 50 to 1250 min according to age and PS on day 1,8,15 every 28. Immunotherapy (IT) was IL2 3MU subcutaneously daily for 5 days a week or Alfa-INF 3MU three days a week, chronically given. Results: We enrolled 23 pts; 5 female; median age 59 years (29–75), all stage IV disease, all nephrectomized with histologically confirmed clear cell carcinoma; median Fhurman’s grade was 3 (1–4); median PS was 2 (0–3); 9 pts had bone mets; prior treatments: IT, mostly low doses IL2, in 12 pts; chemotherapy in 7 pts and palliative radiotherapy in 9 pts. 125 cycles (median of 5, range 1–35) were administered with a median G dose of 1050 mg/m2 over 105’. 13 Pts received IT (11 pts were IT naïve and received IL2 and 2 pts previously treated with IL2 received Alfa-INF). In the 22 pts valuable for toxicity grade 1–2/#pts was: granulocytopenia/5, anemia/2, nausea/5, vomiting/2, constipation/1, mucositis/1, fever/1, infection/1, fatigue/2, cutaneous/5, peripheral edema/4; grade 3–4 was: anemia/3, nausea/1, fatigue/3, cutaneous/1, vascular venous/1, peripheral edema/1. 26 cycles had to be delayed due to side effects. In the 22 valuable pts we reported 3 PR with a RR of 14% and 11 pts (50%) had SD. All pts were valuable for TTP with a median of 5.6 months (1–35). Data on OS are still immature with a median of 15+ (3–55+). Conclusions: FIR-G ± IT is safe and moderately effective against ARCC. Due to the small number of pts no separate analysis is possible between G ± IT or prognostic factors groups. Nevertheless our TTP and OS data are promising considering the detrimental prognostic factors in the treated population. Present work was part of studies program of, and partly supported by, AOI (Associazione Oncologia Italiana), Padova, Italy. No significant financial relationships to disclose.