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e16561 Background: CheckMate 025 demonstrated favorable efficacy and safety results for nivolumab monotherapy in previously treated advanced or metastatic renal cell carcinoma (aRCC). However, real-world evidence on treatment patterns and clinical outcomes is limited. Methods: This multi-centre, retrospective cohort study examined treatment patterns and overall survival (OS) in aRCC patients treated with nivolumab monotherapy. Eligible patients who initiated nivolumab at second-line (2L) or beyond (index) between 01 March 2016 and 30 June 2018 were sampled from four UK centers. Data were extracted using an electronic case report form from index to earliest of: most recent visit; death; end of follow up (31 May 2019). Results: Overall , 151 patients were included in analyses (mean age at index 66.9 years, 72.2% male, median follow-up from index 15.2 months), with 109 (72.2%) and 42 (27.8%) receiving nivolumab at 2L and ≥ third-line (3L+), respectively. Key clinical characteristics are outlined in Table 1. All 2L nivolumab patients had received first-line (1L) tyrosine kinase inhibitors (TKI), pazopanib (57.8%), sunitinib (30.3%), or both in sequence (10.1%). After 2L nivolumab, 3L cabozantinib (36/52, 69.2%) was most common. Most 3L nivolumab patients received 2L TKI (31/36, 86.1%) - commonly axitinib (70.9%). After 3L nivolumab, most patients received fourth-line cabozantinib (8/12, 66.7%). Median time on line of therapy (LOT) decreased with LOT progression: from 7.8 months at 1L to 4.6 months at fifth-line (5L). The proportion of patients who discontinued treatment due to adverse events decreased by LOT, (28.6%, 22.7%, 16.0% and 0%, and 34.7%, 28.1%, 0% and 0% from 2L to 5L, overall and for nivolumab treatment, respectively). Overall, median OS from nivolumab initiation was 19.2 months [95% CI, 16.9-27.0]. Patients who received 2L nivolumab had longest median OS (23.0 months [95% CI, 17.2, not reached]), comparable to CheckMate 025 (25.8 months [95% CI, 22.2-29.8]). Median OS for 3L+ nivolumab patients was 12.4 months [95% CI, 8.8, 23.2]. Among 2L nivolumab patients, 73.9%, 46.2%, and 33.6% survived 12, 24, and 36 months, respectively. For the same respective timeframes, 52.4%, 24.7%, and 18.6% of 3L+ nivolumab patients survived. Conclusions: This study provides real-world evidence on the characteristics, treatment patterns and effectiveness of 2L or ≥ 3L nivolumab monotherapy in previously treated aRCC patients. OS results from UK routine clinical care were comparable to those found in CheckMate 025.[Table: see text]

e13542Background: NCCN Guidelines recommend smoking cessation support for patients who report smoking within the past 30 days. However, few reports have evaluated the utility of standardized questi...

5503 Background: The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced SCCHN. Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating EGFR as a target. Erlotinib, a small molecule inhibitor of EGFR, has activity in recurrent/metastatic disease. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy. Methods: Patients with locally advanced SCCHN were randomized to receive cisplatin 100mg/m2 on days 1,22 and 43 combined with 70Gy of radiotherapy (arm A) or the same chemoradiotherapy combined with erlotinib 150mg/day, starting one week prior to radiotherapy and continued to its completion (arm B). Randomizing 204 patients had 80% power to compare a 60% complete response rate (CRR) to a 40% null rate. Available tumors were tested for p16, ERCC1 and EGFR FISH. Results: Between June 2006 and October 2011, 204 patients were randomized. Results presented are based on intention to treat. There were more females on arm A however no other differences in patient characteristics, including p16 positivity. Patients on arm B had more rash and gastrointestinal adverse events, but treatment arms did not differ for rates of other grade III/IV toxicities or serious adverse events (SAEs). Arm A had a CRR of 61% and arm B had a CRR of 68% (p=0.3). With a median follow-up of 23 months, there were only 29 events in the overall survival analysis and 46 in the progression-free survival (PFS) analysis. The 2 and 3 year PFS were 71% and 63% for arm A and 78% and 73% for arm B (p=0.61). Conclusions: The addition of erlotinib did not increase the rate of SAEs but failed to significantly increase CRR. As seen in other recent trials, our results in both arms are superior to historical comparisons. Updated PFS data will be presented. Supported by a grant from the investigator-initiated trial program of Genentech/OSI.

5580 Background: Cisplatin and radiotherapy is a standard therapy for patients with SCCAHN. Targeting the EGFR pathway in combination with radiotherapy improves survival over radiotherapy alone. Er...

5578 Background: Locally recurrent disease (RD) contributes to the majority of SCCHN-related deaths. In addition, second primary tumors (SPT) develop in approximately 30% of patients (pts) who were cured of their primary malignancy. For pts with disease (RD or SPT) in a previously irradiated region, therapeutic options are limited. Approaches utilizing reirradiation with concurrent chemotherapy (CT) have been investigated, with promising initial results. We retrospectively report the clinical outcome & toxicity of such a regimen. Methods: A cohort of pts with locally recurrent or second primary SCCHN within previous radiation portals were treated with concurrent chemoradiotherapy (CRT). Pts received HFx RT (1.5 Gy/Fx BID × 5 every 2 wks × 4), in combination with DDP 15 mg/m2 IV QD × 5 and P 20 mg/m2 IV QD × 5 q 2 wks × 4. Filgrastim was given on days 6–13 of each 2 wk cycle. Results: Nineteen pts were treated (median age 61; 84% with RD at median of 22 mos, 16% SPT; primary site: oropharynx-32%, larynx-32%, oral cavity 21%). Two pts had treatment discontinued early (due to hemoptysis & declining performance status, respectively). Seventeen pts were evaluable at a median f/u of 13 mos. Acute skin & mucous membrane toxicity (Grade ≥ 2) was seen in 11% and 5% of pt’s, respectively, and 32% of pts developed skin fibrosis as a late radiation toxicity. Most pts (82%) received all 4 scheduled cycles of CT. Grade ≥ 3 hematologic toxicity occurred in 29% of pts (anemia 24%, neutropenia 24%, & thrombocytopenia 12%). Infection was the primary non-hematologic toxicity, with Grade ≥ 3 infection in 29% (4 pneumonia, 1 vascular catheter). There was 1 treatment-related death (hypotension with CVA). Of the 16 pts who completed treatment, 4 had initial surgery, and thus had no measurable disease upon commencing CRT. Objective responses to CRT were noted in all of the remaining 12 pts and 50% achieved a CR. One-year OS rate was 65%, with median survival not yet reached. Conclusions: RD and SPT pts who are not surgical candidates have limited treatment options. Aggressive reirradiation with biweekly CT produces excellent response rates, with acceptable local and systemic toxicities. No significant financial relationships to disclose.

7228 Background: Treatment options are limited for patients with MILC. This is a review of patients with MILC treated with CHERT. Methods: 36 patients with MILC treated between 1998 and 2002. All had a pathologic diagnosis of non-small cell lung cancer (NSCLC); all unresectable [poor pulmonary function (23 patients), prior cancer (10 patients - other lung, 4 lobectomies, 1 wedge, esophageal, and colon cancer), 2 other co-morbidities, 1 refused surgery]. Six had more than one primary tumor; 4 concurrently treated (1 small cell with concurrent chemotherapy). The median age was 69 years. Lesion size was 5cm, 5. All had CT scans of the chest; no mediastinoscopy; staged as N0, 34 and N1,2. Radiation was once daily (6–18MV). Median dose was 80.5 Gy/35 fx/2.3 Gy/fx. Target volume included tumor and nodes measuring 1.0cm or larger; margin was the clinical target within a 90–95% isodose line. The mean treatment volume was 42.7 cm3. Results: Thirty-five completed treatment; med...