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13 Cards in this Set

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What is the evidence that demonstrated the benefit of adjuvant CRT after surgical resection for gastric cancer?
INT 0116 (Macdonald JS et al., NEJM 2001): 556 pts, stage IB-IV (non-metastatic) adenoca of stomach and GE jcn (~20%), randomized after en-bloc resection to neg margin to 1) observation, or 2) CRT (1 cycle bolus 5FU/LV before RT, 2 cycles during 45 Gy RT, and 2 cycles after RT. Median f/u 5 yrs, CRT beneficial in all parameters except for DM 3 yr RFS 48% vs 31%; 3 yr OS 50% vs 41%; median OS 36mo vs 27 mos; LR 19% vs 29%. DM 18% surgery vs 33% CRT (not sig). Only 1% toxic deaths.
What is the major criticism for the benefit of CRT seen for INT 0116 (McDonald)?
Suboptimal LN dissection (54% D0, 10% D2).
What is the data to support using definitve chemo/rt vs rt alone for locally advanced esophageal ca?
RTOG 85-01 Herskovic randomised pts to RT alone (64 Gy) vs RT (50 Gy)+cis/5FU. The 5 yr OS with 27% vs 0% for RT alone.
What is the European study that demonstrated a survival benefit of peri-operative chemotherapy compared to surgery alone for the management of gastric cancer? What is the major weakenss with this approach?
MRC Adjvuant Gastric Cancer Infusional Chemotherapy (MAGIC) trial (Cunningham D et al., NEJM 2006) randomized 503 pts with gastric, GE junction, and distal esophageal adenoca (26%) to 1) preop ECF x3 and postop ECF x3 or 2) surgery alone, showed a survival benefit for chemotherapy. 5 yr OS 36% vs 23% (p=0.009). The major weakness of the MAGIC trial is that the pCR rate = 0%.
Is there a benefit to escalating the RT dose beyond 50.4 when using chemo/rt for esophageal ca? What study supports this?
The Intergroup 0123 by Minsky is a phase III study that randomized pts to 50.5 Gy vs 64.8 Gy with cis/5FU. No difference in LC. excessive deaths in high dose arm. No benefit to higher dose even with deaths excluded.
Describe the standard chemo/rt regimen for esophageal ca as done in RTOG 85-01. What is 5 yr OS?
Definitve Chemo/RT
Standard therapy is from RTOG 85-01
5-FU: 1000 mg/m2 by CI, weeks 1 and 4
CDDP: 70 mg/m2, weeks 1 and 4
RT: 50.4 Gy (this is the standard!)
5-yr OS: 27%
The largest study to date to look at the effects of preoperative chemoradiotherapy in advanced esophageal cancer has found that a combination regimen of chemotherapy and radiation before resection is superior to surgery alone--describe this study and its results.
phase III multicenter CROSS trial, involving 364 patients in the Netherlands with resectable esophageal adenocarcinoma or squamous cell carcinoma, the median survival of patients who received chemoradiation (CRT) and surgery was 49 months, compared to 26 months for those who received surgery alone. With a median follow-up of 32 months, 70 patients had died in the CRT group vs 97 in the surgery-alone group, and 3-year overall survival was superior in the CRT arm. The CRT regimen used in the CROSS trial-paclitaxel with carboplatin and 41.4 Gy radiotherapy-was well tolerated, CRT with surgery improved outcomes most for patients with squamous cell carcinoma (HR = 0.34), who comprised 23% of patients treated in both arms of the trial.
Is surgery necessary after chemo/rt for esophageal ca? What study addressed this? Practically, what is the approach to adding surgery?
Stahl compared chemo/RT +/- surgery and found no difference in survival--increased loco-regional control but increased mortality with surgery. The stahl trial was predominantly squamous cell.
The Walsh Esophagus trial did show a survival benefit with pre-op chemo/rt vs surgery alone. What were the problems with this study?
Small number of patients with adeno and very high mortality in the surgery alone arm.
What is the evidence that demonstrated the benefit of adjuvant CRT after surgical resection for gastric cancer?
INT 0116 (Macdonald JS et al., NEJM 2001): 556 pts, stage IB-IV (non-metastatic) adenoca of stomach and GE jcn (~20%), randomized after en-bloc resection to neg margin to 1) observation, or 2) CRT (1 cycle bolus 5FU/LV before RT, 2 cycles during 45 Gy RT, and 2 cycles after RT. Median f/u 5 yrs, CRT beneficial in all parameters except for DM 3 yr RFS 48% vs 31%; 3 yr OS 50% vs 41%; median OS 36mo vs 27 mos; LR 19% vs 29%. DM 18% surgery vs 33% CRT (not sig). Only 1% toxic deaths.
5FU: 400 mg/m2 and LV 20 mg/m2
What is the recent study that demonstrated a survival benefit of peri-operative chemotherapy compared to surgery alone for the management of gastric cancer? What is the major weakenss with this approach?
MRC Adjvuant Gastric Cancer Infusional Chemotherapy (MAGIC) trial (Cunningham D et al., NEJM 2006) randomized 503 pts with gastric, GE junction, and distal esophageal adenoca (26%) to 1) preop ECF x3 and postop ECF x3 or 2) surgery alone, showed a survival benefit for chemotherapy. 5 yr OS 36% vs 23% (p=0.009). The major weakness of the MAGIC trial is that the pCR rate = 0%.
ECF=epirubicine, cisplatin, 5FU
What is your approach to the post-op treatment of a resected pancreas ca patient? What is the basis for this approach and doses?
I would use a sandwich therapy approach with gemcitabine 1000mg/m2/d x 3 wks followed by concurrent xrt/5FU (50.4Gy with CI 5FU250 mg/m2/dfollowed by another 6 weeks of gemcitabine 1000mg/m2/d. This is based on RTOG 9704 randomized R0 and R1 pancreatic adenoCa pts to 5-FU chemo/RT (50.4Gy) and pre and post chemo/RT with either additional 5-FU or gemcitabine. Among all eligble pts, there were no differences. In a preplanned subset analysis, pts with pancreatic head tumors, trends favored gemcitabine, median OS 20 mo vs 17 mo and 3 yr OS 31% vs 22% but results not SS (p=0.09). (Regine W et al., JAMA, 2008)
What is the basis for the treatment paradigm for superior sulcus tumors?
Induction chemoradiation based on SWOG 9416 allows R0 resection in 75%, good local control, and 5-year survival 44%

SWOG 9416 (1995-1999) -- Induction chemo-RT, surgery, adjuvant chemo
Prospective. 110 patients, solitary T3-T4 N0-N1 superior sulcus NSCLC. Induction chemo-RT (cisplatin 50 mg/m2 and etoposide 50 mg/m2 + RT 45/25 to primary tumor and ipsilateral SCV but not mediastinum/hilum.) Restaging 2-4 weeks later for surgery (lobectomy or pneumonectomy, with en-block resection of tumor, and mediastinal dissection). Thereafter adjuvant cisplatin/etoposide x2 cycles. No adjuvant RT
4-years; 2007 PMID 17235046 -- "Induction chemoradiation and surgical resection for superior sulcus non-small-cell lung carcinomas: long-term results of Southwest Oncology Group Trial 9416 (Intergroup Trial 0160)." (Rusch VW, J Clin Oncol. 2007 Jan 20;25(3):313-8.) Median F/U 3.7 years
Compliance: induction completed by 95%, thoracotomy in 80%, R0 resection in 76% (94% of those going to surgery), pCR in 29% (36% of those going to surgery). PCR or microscopic residual disease was seen in 56% of the patients. Postop mortality 2%
Outcome: median OS 2.7 years, if R0 resection 7.8 years. 5-year OS 44%, if R0 resection 54%. No difference between T3 and T4. LR 17%, LR+DM 12%, DM 67% (~50% brain only)
Conclusion: Combined modality approach feasible, LC and OS seem improved relative to prior studies. Complete resection necessary for good outcome