e18022 Background: Docetaxel (D) is active in advanced NSCLC. Bevacizumab (B) enhances conventional chemotherapy with increased response rate and prolonged survival. The study objective is to evaluate efficacy and safety of D and oxaliplatin (O) in combination with B as first-line therapy in patients (pts) with non-squamous IIIB/IV NSCLC. Methods: Pts with non-squamous, IIIB/IV NSCLC, measurable disease, Performance Status (PS) ≤ 2, and adequate organ function were treated with D 70 mg/m2, O 100 mg/m2 and B 15 mg/kg, intravenously on day 1 in a q3 week cycle up to 6 cycles. B was continued up to a total of one year unless disease progression or unacceptable toxicity occurred. Prophylactic G-CSF was not required. Uncontrolled hypertension and untreated brain metastasis were excluded. Assessments included tumor response (every 6 weeks) and toxicity. Results: Fifty-three pts were enrolled (median age, 62 years; range 36, 77). There were 72% male, 79% Caucasian, 89% stage IV, 94% adenocarcinoma and 6% PS = 2. Among 52 treated pts, a median of 6 cycles were received per pt. 40% patients received at least one cycle of B monotherapy as maintenance. Dose reduction/delay occurred in 19 pts (36%). Nine (17%) pts discontinued treatment due to adverse events. The confirmed overall response rate (ORR) was 30.2% in 16 pts including one complete response (CR). 20 pts (38%) had stable disease (SD). The clinical benefit (CR+PR+SD) was 68%. Median progression free survival was 5.6 months (95% CI: 2.9, 7.9). Median time to treatment failure was 4.7 months (95% CI: 2.9, 5.6). Median overall survival was 14 months (95% CI: 10.3, 18.1). The commonly reported grade (G) 3/4 adverse events included neutropenia (15%) diarrhea (14%), fatigue (12%), and dehydration (10%). One G3 neuropathy (1.9%) and no G3/4 hemoptysis were reported. Four deaths occurred during treatment period and one (pneumonia) was considered treatment related. Conclusions: The docetaxel, oxaliplatin and bevacizumab regimen showed favorable clinical activity in this setting, comparable with historical results of antiangiogenic therapy. This triplet has shown an acceptable toxicity profile. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis Genentech, sanofi-aventis Genentech, sanofi-aventis

7582 Background: We evaluated the efficacy and safety of carboplatin (C) and irinotecan (I) concomitantly with radiation therapy followed by docetaxel (D) in patients (pts) with stages IIIA/B NSCLC. Methods: We enrolled 32 pts. The daily dose of radiation was 1.8 Gy, 5 days a week for 5 weeks, 25 fractions, (45 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV. After 45 Gy, the primary tumor and involved nodal metastasis (secondary planning target volume: SPTV) was boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose given was 63 Gy in 35 fractions over 7 weeks. C was given with an AUC=2 and I was given at 30mg/m2 both of them weekly for 7 weeks. D was given at 75mg/m2 as consolidation chemotherapy for 3 cycles. Results: Median age was 55 years (range: 42–78), most pts were females (74%), 57% were Caucasian and 57% were Hispanic. The most common histologies were poorly differentiated and squamous cell carcinomas. Half of the pts were stage IIIB. The overall response rate (ORR) was 63% (95%CI: 43.7 to 78.9%). Three pts achieved complete response (CR) and 17 pts partial response (PR). Also, 5 pts (16%) achieved stable disease (SD) for a disease control rate of 79% (63%+16%). Overall survival at 1 and 3 years were 55% (95% CI, 35% to 71%), and 34% (95% CI, 12% to 57%), respectively. Median survival was 16.6 months. Thirteen of 31 patients treated (41%) developed clinical radiation pneumonitis (RP). Clinical RP is expected in about 5–35% of pts treated with thoracic irradiation, and asymptomatic radiological findings might be found in as many as 50% of pts. The risk of RP depends on the dose and volume of lung exposed. Different literature data reported a correlation between the occurrence of RP of grade 2 or higher and dose-volumetric parameters (V20). If the V20 of pts treated is <31% then less than 10% of the pts will develop RP, however if the V20 >32% then 13–36% of the pts will develop RP. In our study the V20 was approximately 30%, for that reason we believe that the increase in the incidence of RP in our study is most probably due to this chemotherapy combination with radiation. Conclusions: The CI combination with radiation therapy is effective for the treatment of stage III NSCLC however the rate of RP might be too high for the expected toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis Pfizer, sanofi-aventis Pfizer, sanofi-aventis

16524 Background: Prognosis is very poor when patients with head and neck (H/N) squamous cell carcinomas (SQCC) present with systemic metastasis or disease relapse after primary therapy. (Survival less than 6 months despite palliative therapy). Capecitabine (Xe) is a rationally designed, oral, tumor-selective fluoropyrimidine that mimics continuous 5-FU infusion. Oxaliplatin (Ox) is an alkylating agent that is not generally cross-resistant to cisplatin or carboplatin, and it was shown to be more effective that cisplatin and with increase the antitumor activity of 5-FU in tumor models. Methods: The objective of this study was to determine the safety and efficacy of this new combination (XELOX) for pts with H/N SQCC. Based in two phase I studies with solid tumors we choose the combination of Ox: 130mg/m2 IV day 1, and Xe: 850 mg/m2 PO BID day 2 to 15 every 21 days. Pts were treated until there is disease progression or received a maximum of 6 cycles. All pts had metastatic or relapsed H/N SQCC and they had not received chemotherapy yet for their metastatic or relapsed disease. Results: We have enrolled 16 pts. The enrollment was slower than predicted because several patients that were elegible were not enrolled because they were not able to swallow Xe due to the presence of feeding tubes. The median age was 61 years (range 46–78), most of them were males (10/16), smokers (13/16), whites (13/16), with ECOG PS 1 (11/16), and with Hispanic heritage (10/16). Eleven of them had metastasis to the lungs already and most of the pts had already received chemotherapy (9/16) or radiation therapy (14/16) during the initial therapy. Two pts withdraw consent and were not treated. From the 14 eligible pts to asses response we had 2 partial responses and 6 disease stabilizations. From 47 cycles administered we have seen few grade ¾ adverse (all of them less 10%) events including: leucopenia, hyponatremia, hoarseness, hyperglycemia, depression, and respiratory failure. Two pts reported grade 3 tumor pain. Conclusion: This study shows that the XELOX combination is probably safe and might be effective in the palliative therapy of patients with relapsed or metastatic SQCC of the H/N with these poor prognostic features. No significant financial relationships to disclose.

17088 Background: Irinotecan (I) has an active role and potential as a radiosensitizing agent in patients with NSCLC. SWOG 9504 established the concept of “consolidation” chemotherapy with 3 cycles of docetaxel (D) after chemo/radiation (CRXT). We evaluated the efficacy and safety of administering weekly doses of carboplatin/irinotecan (CI) concomitantly with radiation therapy followed by D chemotherapy for patients (pts) with stages IIIA/B NSCLC. Methods: We have enrolled 23 pts, treatment included: C: (AUC = 2) and I: 30 mg/m2, weekly concomitant with radiation therapy, and D: 75 mg/m2 every 3 weeks for 3 times after CRXT was finished. The daily administered dose of radiation was 1.8 Gy, 5 days a week for 5 weeks, 25 fractions, (45 Gy) to the primary tumor and mediastinum (primary planning target volume: PPTV. After 45 Gy, the primary tumor and involved nodal metastasis (secondary planning target volume: SPTV) was boosted at 2 Gy per day to 18 Gy in 9 fractions. The total dose given was 63 Gy in 35 fractions over seven weeks. Evaluation of response has been done with RECIST criteria. Results: Median age is 55 years (range: 42–78), 18 (78%) of the pts are female, 17 (74%) are white, 13 (57%) are Hispanic, and 14 (65%) had an ECOG 1. Most common histologies are poorly differentiated and squamous cell carcinomas: 14 pts (61%), and half of the pts are stage IIIB. 111 weeks of CI and 39 cycles of D have been administered and we have documented 22 grade 3/4 adverse events (AE) among them: 4 pts pneumonia (17%), 3 pts radiation pneumonitis (13%), 2 pts: dehydration o neutropenia o dyspnea (9%) and 1 pt with diarrhea, nausea and vomiting (4.5%). No grade 4 neutropenia, esophagitis or diarrhea was reported. 12 severe AE were reported including: 2 pts with pneumonia (9%), 2 pts with dehydration (9%), and 2 pts with radiation pneumonitis (9%) requiring hospitalization. The rest of SAE were unrelated to therapy. Data for response is available in 18 pts. A partial response was seen in 10 pts (56%), and stable disease in 6 pts (33%). 2 pts are ineligible for response. Median survival (and PFS) has not been reached and it will be presented in the meeting. Conclusions: CI administered with radiation therapy and followed by D is safe and efficacious in the treatment of stage III NSCLC. [Table: see text]