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Background Standard therapy for stage III non-small cell lung cancer with chemotherapy and conventional radiation has suboptimal outcomes. We hypothesized that a combination of surgery followed by stereotactic body radiation therapy (SBRT) would be a safe alternative. Methods Patients with stage IIIA (multistation N2) or IIIB non-small cell lung cancer were enrolled from March 2013 to December 2015. The protocol included transcervical extended mediastinal lymphadenectomy (TEMLA) followed by surgical resection, 10 Gy SBRT directed to the involved mediastinum/hilar stations and/or positive surgical margins, and adjuvant systemic therapy. Patients not suitable for anatomic lung resection were treated with 30 Gy to the primary tumor. The primary efficacy end-point was the proportion of patients with grade 3 or higher adverse events (AE) or toxicities. Results Of 10 patients, 7 patients underwent neoadjuvant chemotherapy. All patients had TEMLA. Nine of 10 patients underwent surgical resection. The remaining patient had an unresectable tumor and received 30 Gy SBRT to the primary lesion. All patients had post-operative SBRT. Median follow-up was 18 months. There were no perioperative mortalities. Six patients had any grade 3 AEs with no grade 4–5 AEs. Of these, 4 were not attributable to radiation. Pulmonary-related grade 3 AEs were experienced by 2 patients. There were no failures within the 10 Gy volume. Overall survival and progression-free survival rates at 2 years were 68% (90% CI 36–86) and 40% (90% CI 16–63), respectively. Conclusions In carefully selected patients with locally advanced non-small cell lung cancer, combining surgery with SBRT was well tolerated with no local failure. Trial registration ClinicalTrials.gov identifying number NCT01781741. Registered February 1, 2013.

Purpose: To determine the maximal tolerated dose of capecitabine with oxaliplatin + radiotherapy in a phase I study of localized esophageal cancer. Patients and Methods: Oxaliplatin (85 mg/m2) administered on days 1, 15, and 29. Capecitabine administered twice daily 5 days weekly; dose levels (DL) were 1, 1000; 2, 1250; and 3, 1500 mg/m2 with 50.4 Gy radiation. Results: Dose-limiting toxicity was reached at DL 3. Carboxylesterase expression in day 2 tumor specimens and induction correlated with response (p ≤ 0.05). Conclusion: The maximal tolerated dose was 85 mg/m2 of oxaliplatin, 1,250 mg/m2/day of capecitabine, and 50.4 Gy of radiation.

Purpose: The combination of oxaliplatin, 5-fluorouracil, and leucovorin with concurrent radiotherapy was demonstrated to be a safe regimen for locally advanced esophageal carcinoma in a prior phase I study. We now report the efficacy data for 42 patients treated with this regimen. Methods: Each chemotherapy cycle lasted 29 days and consisted of 5-fluorouracil, 180 mg/m 2 protracted-infusion from days 1 to 29, and oxaliplatin, 85 mg/m 2 on days 1,15, and 29. The first cycle was administered concurrently with radiation. The radiation field included regional lymph nodes as well as the primary tumor or tumor bed to a dose of 50.4 Gy in 28 fractions. After concurrent chemoradiotherapy, 1 to 2 additional cycles of chemotherapy were administered. If esophagectomy was indicated, it occurred 4 weeks after completion of concurrent chemoradiotherapy. In the adjuvant group, concurrent chemoradiotherapy was initiated 4 weeks after surgery. Results: Median age was 61 years (range 38-78 years); 30 (71%) of the patients were male. Thirty-three patients had adenocarcinoma, and 9 had squamous cell carcinoma. Concurrent chemoradiotherapy was administered preoperatively (group 1) in 24 patients, definitively (group 2) in 13 patients, and as adjuvant treatment (group 3) in 5 patients. In group 1, 16 patients were down-staged including 1 patient with minimal residual disease and 5 with a complete pathologic response; 4 patients were not down-staged, and 4 did not undergo esophagectomy (2 progressed, 1 died of unrelated causes, and 1 refused). In group 2, 1 patient had a complete clinical response, 4 others were down-staged, 2 had stable disease, and 6 progressed. Four patients in group 3 progressed. Median survival was 28 months for group 1, 12 months for group 2, and not reached at 14 months for group 3. There was one grade 4 toxicity (anaphylaxis) in group 2. Grade 3 toxicities were reported for 5 patients in group 1 and 1 patient in group 2. They consisted of hypotension (n = 1), fatigue (n = 2), diarrhea (n = 2), neuropathy (n = 1), mucositis (n = 1), pneumonitis (n = 1), dehydration (n = 1), emesis (n = 1), and weight loss (n = 1). Conclusions: Our study supports the incorporation of oxaliplatin into a multimodal concurrent chemoradiotherapy protocol for locally advanced esophageal cancer.

Endoscopic resection (ER) is an important advance in the management of esophageal tumors. It has been used successfully for superficial esophageal cancer and high-grade dysplasia (HGD) arising out of Barrett epithelium. From a single institution within the Department of Surgery, patients who underwent ER for esophageal tumors between December 2001 and January 2012 were evaluated. Demographic, clinical, and pathologic variables were collected and reviewed. We identified 81 patients who underwent ER for esophageal lesions. Median patient age was 69 years, and the median follow-up was 3.25 years. In patients with HGD, at the time of last endoscopy, the complete eradication rate of HGD was 84 % and cancer-specific survival was 100 %. During surveillance, one patient developed an invasive carcinoma that required endoscopic therapy. Patients with T1a and negative deep margins on ER had a recurrence-free and cancer-specific survival of 100 %. There were seven patients with T1b and negative margins on ER. Three patients underwent esophagectomy; final pathology revealed no residual malignancy or lymph node metastasis. Two patients had definitive chemoradiation, and two patients were observed. To date, there has been no cancer recurrence. In all patients who underwent ER, there was one episode of bleeding that required endoscopic treatment and admission for observation. ER can be performed safely and can adequately stage and often treat patients with HGD and superficial cancers. Patients with HGD and T1a disease with negative margins are cured with ER alone. Observation and surveillance may be an option for select patients with low-risk, early submucosal disease (T1b) and negative margins.

Therapeutic options for locoregional esophageal cancer (EC) include primary surgery, neoadjuvant or definitive chemoradiation and systemic chemotherapy. The role of surgery in these multimodal strategies has recently been debated and definitive chemoradiation is being offered as an alternative to surgery at many centers. We examined our results with multimodal therapy and surgery in this patient population. We conducted a retrospective analysis of 172 patients with locoregional (AJCC stages I-III) EC treated at RPCI between February 14, 1990 and September 20, 2002. Median age was 65 years (range, 36-95); there were 136 male patients. There were 100 regional (stages IIB-III), 69 local (stages I-IIA) and three in situ cases. Initial therapy was either combined modality (n = 122) or single modality (surgery) (n = 50). There was 0%, 30-day, postoperative mortality. Median survival for all patients was 25.3 months and was better for local stage with surgery alone (75 months) than with neoadjuvant (35.7 months) or definitive chemoradiation (19.1 months, P < 0.001). Survival for patients with regional disease treated with surgery alone, neoadjuvant or definitive chemoradiation was 21.5, 24.4 and 11.8 months, respectively (P = not significant). The associations of prognostic factors with overall survival were evaluated using Cox proportional hazards regression analysis and 2-sided Wald's chi-square test. On multivariate analysis, carefully selected patients treated with surgery alone had better outcomes compared with those treated with definitive chemoradiation (P < 0.001). Patients with locoregional esophageal cancer who are eligible for surgical resection either alone or as a part of multimodal therapy may have better outcomes than those treated with non-surgical approaches.

Approximately 21% of patients with advanced malignancies have cardiac or pericardial involvement with tumor. Controversy exists regarding the optimal approach to the pericardial space when hemodynamic compromise due to effusions occurs.A six-year retrospective review of 59 cancer patients with pericardial effusions.Thirty-six patients had subxiphoid pericardial window (SXPW) alone (Group A), 5 had pericardial catheter drainage (PCD) followed by a SXPW (Group B), 10 had PCD with sclerosis (Group C), 5 had PCD alone (Group D), 2 had PCD with pericardial-pleural window (Group E), and one had pericardial-peritoneal window (Group F). The method of procedure, complications, number of hospital and ICU days, cytological or pathologic evidence of malignancy, solid versus hematological tumors, and survival were analyzed. The median survival for those patients in group C was one month compared to 4 months for Group A and 6 months for Group B. Essentially, results were similar regardless of method performed with the exception that professional and hospital charges averaged $4830 for SXPW compared to $1625 for PCD.Pericardial catheter drainage and sclerosis provides a viable option for the treatment of pericardial effusions in selected cancer patients at markedly reduced cost and patient discomfort.

4100 Background: A pCR following chemoradiation (CRT) is associated with improved survival in EC patients (pts). Our prior study noted the safety of combination C, OXP and RT. The present phase II ...

e15619 Background: Multimodal therapy is considered standard for LAEC with cisplatin and 5FU-based CRT being commonly used, though with significant toxicity. Novel agents are needed to improve pathologic response (pCR) which predicts for better prognosis. We analyzed our experience with CRT using I + C in LAEC. Methods: LAEC patients (PTS) who underwent surgery preceded by CRT with I + C were identified from the Roswell Park tumor registry. Treatment consisted of Day 1,8 of C 30mg/m2 and I 65mg/m2in a 21 day cycle. PTS concurrently received 45–50.4 Gy radiation in1.8Gy fractions. Data retrieved included toxicity, pCR rate and survival. Results: 44 eligible PTS, median age 61 yr, 43 males and 1 female. Histology included adenocarcinoma (n=38), squamous cell (n=4), mixed (n=2); 12 PTS had signet-ring cell features. 29 PTS had poorly differentiated tumors. Clinical stage was II (n=5), III (n=24), IVa(n=6), IVb(n=1), not available (n=8). ECOG PS was 0 (n=34) and 1 (n=10). Most common toxicities observed were fatigue (n=24), diarrhea (n=19), vomiting (n=15), hematologic (n=11), constipation (n=11) and neurologic (n=7). Dose delay or reduction was required in 10 PTS, usually from hematologic toxicity. Of these,1 week delay in 45% and 2 weeks in 36%; 1 PT discontinued treatment due to toxicity. There was no CRT-related mortality. 2 PTS died post-operatively (anastamotic leak and sepsis). Dyphagia improved in 33/35 (94%) PTS following CRT. All PTS underwent R0 resection and pCR rate was 25% (11/44). 15 PTS have experienced recurrence. The median disease-free and overall survival is 24 months and 34 months, respectively; 3-yr overall survival is 46%. Available pre- and post-CRT FDG uptake on PET imaging in 28 PTS did not correlate with pCR status (p=0.77). Conclusions: Neo-adjuvant CRT with I + C has modest efficacy in the treatment of LAEC and can be given safely in the out-patient setting. PTS should be monitored closely for toxicity, specifically diarrhea that requires prompt intervention. Efficacy results appear better than those reported in ECOG 1201. This regimen is being evaluated in CALGB 80302 and results are awaited. No significant financial relationships to disclose.