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15043 Purpose: To evaluate the response rate, survival and toxicity of non-metastatic pancreatic cancer patients treated with a combination of, Gemcitabine, Bevacizumab and Radiotherapy. Materials and Methods: Eligibility included patients with non- metastatic pancreatic cancer, standard organ function and ECOG performance status of 0 or 1. The patients received three cycles of therapy. Cycle one was 21 days and consisted of Gemcitabine days 1 and 8 and Bevacizumab days 1 and 15. Cycle 2 was 28 days and consisted of Gemcitabine days 1, 8, and 15, Bevacizumab days 8 and 22 and Radiotherapy days 1–5, 8–12, and 15–19. Cycle three was 21 days and delivered Gemcitabine days 1 and 8, and Bevacizumab day 8. The Gemcitabine dose was 1,000 mg/m2, Bevacizumab at 10 mg/kg and Radiotherapy was delivered to the gross tumor volume only for a total dose of 36 Gy at 2.4 Gy/fraction. Response was determined on week ten with cross sectional imaging and CA 19–9. Toxicities were scored utilizing CTC version 3.0. Resectable patients were to undergo surgery 8 (currently amended to 6) weeks after the last dose of Bevacizumab. Results: Ninteen patients have been enrolled on study from 10/10/05 - 1/4/07. Twelve patients are evaluable for toxicity and response. Ten (83%) had a grade 3 toxicity. The grade 3 toxicities included cytopenias (9), DVT (2), Dehydration (2), hypotension (1), mucositis (1), increased LFT’s (2), Anorexia (1), nausea (1) and fatigue (1).There were no Grade 4 or 5 toxicities. All but one patient completed all three cycles. Radiographic response at 10 weeks was noted to be stable in 10 (83%) patients. Two patients progressed distantly (liver and abdomen). The mean CA 19–9 pre and post treatment CA 19–9 was 1519.56 and 356.09 respectively. One patient underwent surgical resection. The mean follow up is 4.83 months. At last follow up nine patients were alive. Conclusions: The combination of full dose Gemcitabine, Bevacizumab and Radiotherapy was generally well tolerated with no Grade 4 toxicities and the majority of Grade 3 toxicities hematologic. All but one patient completed all three cycles. Responses were limited to a reduction in CA 19–9. Nine patients remain alive. Accrual to the trial continues. No significant financial relationships to disclose.

9008 Background: Gemcitabine chemotherapy for APC is palliative and confers only modest survival advantage. Therefore HRQL concerns are of paramount importance. Methods: We compared HRQL scores based on response to chemotherapy at the first interval restaging (8 weeks). We evaluated HRQL at baseline on paper, and then q8 weeks by phone using the EQ5D instrument in patients with APC participating in a double-blind, randomized trial comparing overall survival for gemcitabine with bevacizumab (GB) or placebo (GP). The EQ5D is a HRQL measure whose composite (C) and visual analog scale (VAS) scores respectively reflect societal and patient valuations. Results: Among 552 patients starting protocol treatment, characteristics did not differ between 359 who did and 193 who didn’t complete baseline assessments. Patients who didn’t complete 8 week assessments were more likely to have died, progressed or discontinued protocol therapy. Changes in EQ5D scores from baseline to 8 weeks did not differ by treatment arm (p-values=0.84, 0.79 for C and VAS scales, Wilcoxon rank sum test). At 8 weeks, all patients and those with progressive disease had a modest decline in VAS scores (p-values≤0.02, Wilcoxon signed rank test). Comparisons of changes from baseline in C scores at 8 week follow-up revealed no differences within other response group strata (all p-values > 0.05). Conclusions: Based on this preliminary analysis, gemcitabine therapy was not associated with higher HRQL scores, nor was there any strong association between tumor response and HRQL. To increase data representativeness, future APC trials should assess HRQL more often than every 8 weeks. HRQL Scores Based on Gemcitabine Response Strata. Values are Mean (SD) [Table: see text] [Table: see text]

4524 Background: Gemcitabine is the mainstay of Rx for pts with APC. Practice guidelines encourage participation in trials after disease progression. We evaluated Rx after APC progression for pts in CALGB 80303 a randomized trial of gemcitabine + bevacizumab (GB) or placebo (GP). Methods: Of the 552 pts who began GP or GB Rx, 457 had comprehensive medical record review. Of these 355 progressed on protocol Rx. We evaluated post-progression Rx for these 355 pts - the record review (RecR) group. We also phoned a subgroup of 126 pts to inquire about Rx delivered at sites other than the accruing center - the record review & interview group (RecR + I) to determine whether any Rx had been administered and the specific agents used. Results: ChemoRx after progression on gemcitabine was distinctly uncommon. Based on RecR 239/355=67.3% and on RecR + I, 70/126=55.6% of pts received no chemoRx after progression on the study Rx. These proportions did not vary based on Rx assignment. Worse ECOG performance status at baseline and older age were associated with lower likelihood of post progression Rx. Notably, 99/355=27.9% of pts died within 4 weeks of progression. Conclusions: After progression on a clinical trial of gemcitabine Rx, [Table: see text] [Table: see text]

3608 Background: UFT, an oral fluoropyrimidine consisting of Tegafur plus uracil (1:4 molar ratio), constitutes a readily absorbed combination agent inhibiting DPD and is reliably converted to 5FU....

4030 Background: The results of a phase 1 study of pegamotecan have been published.1 This phase 2 study was designed to evaluate the activity of pegamotecan in advanced and metastatic adenocarcinomas of the stomach and GE junction. Methods: This multicenter, open-label, single arm study utilized a Fleming 2-stage design. Fifteen subjects were enrolled in the first stage; one response allowed for enrollment of 20 additional subjects. Eligibility criteria included: pathologically confirmed measurable adenocarcinoma of the stomach or GE junction, performance status 0–2, ≤ 1 prior chemotherapy regimens, no prior treatment with a camptothecin analog. Pegamotecan was administered at 7,000 mg/m2 q 3 weeks. The primary endpoint was response rate (RECIST). Secondary endpoints included safety and tolerability, survival, and patient benefit parameters. Results: Preliminary data are available for 15 subjects who received a total of 52 cycles (range 1 – 10). The median age was 62 years (range 36 – 79). Partial respons...

The NCCN Clinical Practice Guidelines in Oncology for Colon Cancer begin with the clinical presentation of the patient to the primary care physician or gastroenterologist and address diagnosis, pathologic staging, surgical management, perioperative treatment, patient surveillance, management of recurrent and metastatic disease, and survivorship. The NCCN Colon Cancer Panel meets annually to review comments from reviewers within their institutions and to reevaluate and update their recommendations. In addition, the panel has interim conferences as new data necessitate. These NCCN Guidelines Insights summarize the NCCN Colon Cancer Panel's discussions regarding the treatment of localized disease for the 2013 update of the guidelines.