Annual Meeting Proceedings Part 1 - American Society of Clinical ...

4059 General Poster Session (Board #43B), Mon, 8:00 AM-12:00 PM
Inequal benefits from regionalization of cancer care: The pancreatic cancer
surgery paradigm. Presenting Author: Theodore P. McDade, Surgical
Outcomes Analysis & Research, University of Massachusetts Medical
School, Worcester, MA
Background: Regionalization has been proposed for high-level care, including
multidisciplinary cancer treatment and complex procedures. Pancreatic
resections can serve as a marker for both. Using Massachusetts
Division of Health Care Finance and Policy (DHCFP) data, we investigated
regionalization of surgery for pancreatic cancer (PCa), its potential effect
on perioperative outcomes, and disparities in access to high-volume PCa
surgery centers. Methods: Using MA DHCFP Hospital Inpatient Discharge
Data, 2005-2009, 10,524 discharges for PCa were identified, of which
746 were associated with pancreatic resection. Discharges with missing or
out-of-state residence were excluded (n�704). Using geodetic methods
and ZIP codes, center-to-center distances were calculated between patient
(pt) and treating hospital. Median ZIP income was estimated from 2009
census data. High volume hospitals (4 of 25 performing pancreatic
resections in MA) were defined using Leapfrog Criteria (� 11 per year (87th percentile for MA). Chi-square and logistic regression analyses were
performed using SAS software. Results: Median age was 65. Pts were
predominantly White (87.2%), with median ZIP income of $54,677. Pts
travelled in-state up to 112 miles (median 15.4), with the majority
resected at high volume hospitals (76%). Median length of stay (LOS) was
8.0 days, with LOS�1 week associated with low volume hospitals
(p�0.0002). Of 14 in-hospital deaths, 7 were at low volume hospitals
(4.14% of 169 pts) compared to 7 at high volume hospitals (1.31% of 535
pts) (p�0.0214). Predictors of shorter travel distance were: Black race (OR
4.45 (95% CI 1.66-11.93)), operation at low volume hospital (OR 2.62
(95% CI 1.81-3.77), and increased age (per year) (OR 1.02 (95% CI
1.00-1.03), but not sex or median income. Conclusions: Using MA
statewide discharge data, regionalization of pancreatic cancer surgery to
high-volume, better-outcome centers is seen to be occurring. However, it is
not uniform, and disparities exist between groups of cancer pts that do and
do not travel for their care. In the current era of scrutiny on cost, quality,
and access to cancer care, further study into predictors of pts receiving
optimal care is warranted.
4061 General Poster Session (Board #43D), Mon, 8:00 AM-12:00 PM
Phase II trial of bevacizumab, irinotecan, cisplatin, and radiation as
preoperative therapy in esophageal adenocarcinoma. Presenting Author:
David Ilson, Memorial Sloan-Kettering Cancer Center, New York, NY
Background: Preop chemo and radiotherapy (RT) with weekly irinotecan (I),
cisplatin (C) and 5040 cGy is tolerable and active [Cancer, in press].
Bevacizumab (B) � weekly I/C in advanced esophagogastric cancer
increased response rate and PFS without an increase in toxicity [JCO 24:
5201; 2006]. In a phase II trial in esophageal adenocarcinoma (EA) we
combed B � I/C with RT as preop therapy. A toxicity analysis after 10
patients (pts) undergoing surgery indicated no unexpected toxicity with B
[JCO 27: Abstract 4573; 2009], and we completed a planned accrual of 33
pts. Methods: Pts had resectable distal esophageal or Siewert’s I or II EA,
T2-3 or N1 staged by EUS, PET, and CT scan. Induction chemo: I: 50-65
mg/m2 � C: 30 mg/m2 weeks 1,2,4,5, B: 7.5 mg/kg weeks 1 and 4;
Chemort: 180 cGy daily fractions to 5040 cGy, I/C weeks 7,8,10,11� B
weeks 7,10. Esophagectomy was planned 6-8 weeks after RT. Postop: B:
7.5 mg/kg every 3 weeks for 8 cycles. Results: 33 pts were enrolled. 26
male: 7 female; distal esophagus 11 (33%), GEJ 22 (67%); 21 T3N1
(64%); 10 T3N0 (30%); 2 T2N0-1 (6%). 25/33 pts went to surgery (76%),
24 had R0 resection (73%). Pathologic CR 5 pts (15%). 8 pts did not going
to surgery: 2 for adverse events (9%, 1 CVA due to patent foramen ovale, 1
esophageal perforation due to endoscopic biopsy), 6 for progressive disease
(18%). 21/24 pts (88%) received adjuvant B, 20 (95%) completed all
cycles. Grade 3/4 toxicity in 30 evaluable pts during chemort: 24%
neutropenia, 3% neutropenic fever, 23% esophagitis, 13% dehydration,
13% thrombocytopenia, 7% pulmonary embolism, 3% nausea/vomiting.
Surgical complications: 3 anastomotic leaks (12%), 4 respiratory failure
(16%), 1 pulmonary embolism (4%), 2 post op deaths (8%). At a median
follow up of 20 months, PFS was 14 months and OS was 30 months.
Conclusions: The addition of B to preop chemoRT in EA was tolerable
without increase in treatment toxicity or surgical complications. There was
no suggestion of improved pathologic CR, PFS, or OS with the addition of B
to I/C/RT. Evaluation of B in phase III trials of chemort does not appear
warranted. Supported by a grant from Genentech.
Gastrointestinal (Noncolorectal) Cancer
253s
4060 General Poster Session (Board #43C), Mon, 8:00 AM-12:00 PM
Choice of chemotherapy in the treatment of metastatic squamous cell
carcinoma of the anal canal. Presenting Author: Cathy Eng, University of
Texas M. D. Anderson Cancer Center, Houston, TX
Background: Metastatic squamous cell carcinoma (SCCA) of the anal canal
is an uncommon malignancy with no standard approach. The reported
median overall survival (OS) is 9-12 months (M) following 5-FU � cisplatin
(FC)-based therapy. The aim of this study is to evaluate first-line chemotherapy
approaches in this patient (pt) population. Methods: A retrospective
analysis was conducted of 428 pts with metastatic SCCA of the anal canal
identified from the MDACC tumor registry between 1/1/2000 - 5/31/2011.
Electronic medical records were reviewed for histology, date of diagnosis
and/or recurrence, site of metastasis, type of therapy provided, response
rate (RR), progression-free survival (PFS), OS, and lines of salvage therapy.
All eligible pts were required to be treatment-naïve for metastatic disease
and have radiographic imaging at MDACC. Waiver of informed consent was
obtained. Results: 99 pts fulfilled all criteria; 10 were lost to follow-up; 12
did not initiate chemotherapy. 77 pts were evaluable; M: F � 20:57;
median age � 55 years (range: 37 - 82); HIV(�) � 5% (4/77); prior
chemoXRT with curative intent: 70% (54/77), complete response (CR):
87% (47/54), median time to development of metastatic disease �17M.
29% (22/77) presented with metastatic disease. Sites of disease included
distant lymph nodes (41%); liver (45 %); lung (25%); bone (15%); and
brain (8%). The median follow up was 37M. 73% (56/77) of patients were
treated with platinum-based therapy; 51% (n�39) received FC and 22%
(n� 17) received carboplatin � paclitaxel (CP). The median PFS was 6M;
FC trended better than CP for PFS (7M vs. 5M, p�0.067). The overall
median OS � 29M. 40% (31/77) of pts received neoadjuvant first-line
therapy followed by metastasectomy (68%), XRT (26%), or both (6%);
resulting in a median OS � 35M. Conclusions: Metastatic SCCA of the anal
canal is a malignancy in which 5-FU�cisplatin is a commonly used
regimen. Our analysis suggests FC results in improved PFS over CP but is
underpowered supporting further analysis. The short median PFS with
front-line chemotherapy, and yet longer OS reflects the challenges in
treating this patient population and the importance of multidisciplinary
management in select cases.
4062 General Poster Session (Board #43E), Mon, 8:00 AM-12:00 PM
A phase II study of neoadjuvant therapy with cisplatin, docetaxel, panitumumab
plus radiation therapy followed by surgery in patients with locally
advanced adenocarcinoma of the distal esophagus (ACOSOG Z4051).
Presenting Author: Carolyn E. Reed, Medical University of South Carolina,
Charleston, SC
Background: Multiple clinical trials have incorporated preoperative chemotherapy
and radiation (RT) in an attempt to improve local tumor control,
distant disease failure and overall survival rates for locally advanced but
resectable adenocarcinoma of the distal esophagus and gastroesophageal
junction (GEJ). This multicenter, cooperative group study combined active
chemotherapy agents cisplatin (C), docetaxel (D) and the targeted EGFR
agent panitumumab (P) in the induction phase followed by concurrent
chemotherapy (CDP) and radiation. Pathologic complete response (pCR), a
surrogate for improved survival, was the primary endpoint. Methods: From
01/15/09 to 07/22/11, 70 patients (pts) with Siewert I or II adenocarcinomas
and clinical stages T3N0M0, T2-3N1M0 or T2-3N0-1M1a (celiac LN
� 2 cm) were accrued. Patients received cisplatin (40 mg/m2 ), docetaxel
(40 mg/m2 ) and panitumumab (6 mg/kg) on weeks 1, 3, 5, 7, 9 with RT
(5040 cGy, 180 cGy/day x 28d) beginning week 5. The decision rule had a
90% power with a 0.10 significance level to detect a pCR rate of at least
35%. Secondary objectives included near-pathologic complete response
(near-pCR), toxicity, and overall and disease-free survival rates. Results:
Five pts were ineligible. Of the remaining 65 pts (59 M, 6 F; median age
61), 12 pts did not undergo surgery (5 progressed, 4 refused, 3 other). Of
the 58 evaluable pts, the pCR rate was 32.8% (90% CI: 22.6% -42.9%)
and near-pCR 22.4% (90% CI: 13.4%-31.4%). Total doses of C, D, and P
were achieved in 76%, 80%, and 73%, respectively (n � 70). 66 pts
(94%) received the total RT dose. Sixteen pts (23%) had a grade 4�
non-heme adverse event possibly related to treatment. Venous thrombosis
(5 pts) was most common. Conclusions: The CDP regimen in the neoadjuvant
setting in patients with esophageal adenocarcinomas is active (pCR �
near-pCR � 55.2%) and feasible. The toxicity though tolerable is substantial.
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