16529 Background: The clinical outcome of refractory head and neck cancer patients remains poor despite novel treatment strategies. In this pilot study we investigated the efficacy of intratumoral injection of 32-P chromic phosphate in 14 patients with refractory head and neck cancers in terms of response rates and overall survival. Methods: Fourteen patients (median age: 59 years) with either cytostatic drug-resistant tumors or tumors known to be primarily chemotherapy-resistant were entered into the study. After sonographic determination of the tumor volume, 32-P chromic phosphate (74–555 MBq) was injected into the central part of the tumor under sonographic guidance. Follow-up investigations included serial scintigraphy, sonographic examinations, and hematologic studies. Results: Injection of 32-P chromic phosphate into refractory head and neck tumors resulted in remarkable regression. The median survival of all patients was 7.8 months (range: 4–16). The response rate (partial response) was 57% (8 patients). However, 6 patients (43%) did not respond to the treatment. In 3 patients thrombocytopenia (grade I/II) was observed, but no other side effects were apparent. Significant pathologic and anatomic changes within the tumor tissue were demonstrated. In all cases examined, formation of a cyst within the area of central activity, surrounded by a centrifugal necrotic ring and a marginal fibrotic structure, was found. Conclusions: Lack of persistent systemic or local side effects, as well as noteworthy efficacy, are properties of this novel regional treatment modality with 32-P chromic phosphate. This modality deserves consideration for further clinical trials. No significant financial relationships to disclose.

Background: Dasatinib is a potent orally active, multi-targeted tyrosine kinase inhibitor that blocks signal transduction pathways implicated in the proliferation and survival of tumor cells. A European compassionate use trial was conducted to provide dasatinib to patients (pts) who were ineligible to be enrolled into the START-trials. Methods: From April 2006 to February 2007, 26 pts were included in Germany. Diagnosis at inclusion: 9 Ph+ALL, 6 CML in accelerated phase, 5 CML in myeloid blast crisis, 2 biphenotypic Ph+ALL and 1 chronic phase CML. Additionally, 3 pts with systemic mastocytosis (SM), refractory to imatinib due to D816V mutation were also included. Pts had previously failed several chemotherapy regimens, including imatinib and/or nilotinib. Sixty-one percent were resistant, 35% were refractory and 4% intolerant to imatinib/nilotinib. Results: Of 26 patients, there were 17 male and 9 female pts. The median age was 56 years (range, 22–80 years). The average daily dose of dasatinib was 137 mg with a median duration of therapy of 69.5d (range 3–252d). Six (23%) pts required transient treatment interruption, 2 (8%) due to non-haematological toxicity (dyspnea and increased hepatic values), 4 (15%) due to haematological toxicities. Twenty-one pts discontinued therapy for the following reasons: study related toxicity (23%), SCT (15%), death (8%), lost to follow-up (11%) and patient’s wish (4%). Two patients still remain on therapy. The response rate was CHR in 42%, complete (CCyR) cytogenetic response in 19%, and PCyR in 4% of the pts. For patients with diagnosed SM one partial HR, one stable disease and one progression have been recorded. Disease progression occurred in 19% of cases. Adverse events were transient and generally mild to moderate in severity. Generally, the observed AE profile was similar to that seen in previous research trials. For all pts, the most common hematological side-effects Grade 3/4 AEs reported were thrombocytopenia (23%), neutropenia (4%), and anemia (4%). Most frequent non-hematological side-effects included dyspnea in 23% of pts (no grade 3–4), edema in 23% (grade 3, 8%), diarrhea in 15% (grade 3, 4%), headache in 15% (no grade 3–4), bone and neck pain in 11% (grade 3, 8%) and pleural effusion in 8% (grade 3, 4%). Conclusions: Dasatinib therapy appeared to be effective and was well tolerated in this difficult to treat patient population.