A equipe do MOC selecionou os abstracts de maior impacto da ASCO 2014. Veja abaixo os destaques em Câncer gastrintestinal:

Câncer de Cólon

• A randomized phase III trial of mFOLFOX6 plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment for metastatic colorectal cancer: West Japan Oncology Group study 4407G (WJOG4407G)
• Adjuvant chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) versus 5-fluorouracil/leucovorin (FL) for rectal cancer patients whose postoperative yp stage 2 or 3 after preoperative chemoradiotherapy: Updated results of 3-year disease-free survival from a randomized phase II study (The ADORE)
• CALGB/SWOG 80405: Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC)
• Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: A first-line phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer (mCRC)
• Final results and subgroup analyses of the phase 3 CAIRO3 study: Maintenance treatment with capecitabine + bevacizumab versus observation after induction treatment with chemotherapy + bevacizumab in metastatic colorectal cancer (mCRC)
• Final results from NSABP protocol R-04: Neoadjuvant chemoradiation (RT) comparing continuous infusion (CIV) 5-FU with capecitabine (Cape) with or without oxaliplatin (Ox) in patients with stage II and III rectal cancer
• Four-year survival in patients (pts) undergoing liver surgery after neoadjuvant triplet hepatic artery infusion (HAI) and intravenous cetuximab (IV-CET) for previously treated and unresectable liver metastases from kras wt colorectal cancer (LM-CRC) (European trial OPTILIV, NCT00852228)
• Preoperative chemoradiotherapy and postoperative chemotherapy with 5-fluorouracil and oxaliplatin versus 5-fluorouracil alone in locally advanced rectal cancer: Results of the German CAO/ARO/AIO-04 randomized phase III trial
• Second-line therapies in patients with KRAS wild-type metastatic colorectal cancer (mCRC) after first-line therapy with FOLFIRI in combination with cetuximab or bevacizumab in the AIO KRK0306 (FIRE 3) trial
• Subgroup analyses in RAS mutant, BRAF mutant and all-wt mCRC pts treated with FOLFOXIRI plus bevacizumab (bev) or FOLFIRI plus bev in the TRIBE study
• Surgical resection of primary tumors (SRPT) in asymptomatic patients with stage IV colorectal cancer (CRC): A Canadian province experience
• Treatment outcome according to tumor RAS mutation status in CRYSTAL study patients with metastatic colorectal cancer (mCRC) randomized to FOLFIRI with/without cetuximab

Câncer de Canal Anal

• A comparison between 5-fluorouracil/mitomycin (FM) and capecitabine/mitomycin (CM) in combination with radiation (RT) for squamous cell carcinoma (SCC) of the anal canal

Câncer de Esôfago

• Chemoradiation with or without nimotuzumab in locally advanced esophageal cancer (LAEC): A randomized phase II study (NICE trial)
• HER-FLOT: Trastuzumab in combination with FLOT as perioperative treatment for patients with HER2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the AIO Gastric Cancer Study Group
• RTOG 0436: A phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin, and radiation for patients with esophageal cancer treated without surgery

Hepatocarcinoma

• A phase II study of temsirolimus in previously treated advanced hepatocellular carcinoma (HCC)
• A phase II trial of second-line axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma (HCC)
• Phase 3 randomized, double-blind, controlled study of cabozantinib (XL184) versus placebo in subjects with hepatocellular carcinoma who have received prior sorafenib (CELESTIAL; NCT01908426)
• RESORCE: An ongoing randomized, double-blind, phase III trial of regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing on sorafenib (SOR)

Tumores de Via Biliar

• Second-line chemotherapy for advanced biliary tract cancer after failure of gemcitabine plus platinum: Results of an AGEO multicenter retrospective study

Câncer de Pâncreas

• APACT: A phase 3 randomized, open-label, multicenter trial evaluating the use of adjuvant nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients (pts) with surgically resected ductal pancreatic adenocarcinoma (PDA)
• Impact of gemcitabine (Gem)- or capecitabine (Cape)-based chemoradiation (CRT) on health-relatedquality of life (HRQL) in patients with locally advanced pancreatic cancer (LAPC): Outcomes from the randomized phase II SCALOP trial
• PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT)

Câncer de Cólon

A randomized phase III trial of mFOLFOX6 plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment for metastatic colorectal cancer: West Japan Oncology Group study 4407G (WJOG4407G)

Abstract No: 3534
Author(s): Kentaro Yamazaki, Michitaka Nagase, Hiroshi Tamagawa, Conclusions: FOLFIRI+Bev was non-inferior to mFOLFOX6+Bev with respect to PFS as 1st-line treatment for mCRC, and showed better trend in QOL.

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Adjuvant chemotherapy with oxaliplatin/5-fluorouracil/leucovorin (FOLFOX) versus 5-fluorouracil/leucovorin (FL) for rectal cancer patients whose postoperative yp stage 2 or 3 after preoperative chemoradiotherapy: Updated results of 3-year disease-free survival from a randomized phase II study (The ADORE)

Abstract No: 3502
Author(s): Yong Sang Hong, Byung-Ho Nam, Kyu-Pyo Kim, et al. Conclusions: Adjuvant FOLFOX demonstrated improved 3-year DFS in curatively resected rectal cancer patients whose postoperative stage of ypII/III after preoperative CRT.

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CALGB/SWOG 80405: Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC)

Abstract No: LBA3
Author(s): Alan P. Venook, Donna Niedzwiecki, Heinz-Josef Lenz, et al.
The full, final text of this abstract will be posted online at 7:30 AM (EDT) on Sunday, June 1.

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Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: A first-line phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer (mCRC)

Abstract No: 3629
Author(s): Fernando Rivera, Lee Steven Schwartzberg, Meinolf Karthaus, et al. Conclusions: In this exploratory analysis, the time and % of pts to biologic subsequent tx were similar between the arms. Median OS was observed to be longer for pts receiving pmab/subsequent anti-VEGF tx relative to pts receiving bev/subsequent anti-EGFR tx and the improvements were similar to that in the total populations of the WT KRAS exon 2 and WT RAS groups.

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Final results and subgroup analyses of the phase 3 CAIRO3 study: Maintenance treatment with capecitabine + bevacizumab versus observation after induction treatment with chemotherapy + bevacizumab in metastatic colorectal cancer (mCRC)

Abstract No: 3504
Author(s): Miriam Koopman, Lieke Simkens, Anne Maria May, et al. Conclusions: Final CAIRO3 results establish the benefit of maintenance treatment with cap + bev after first-line induction treatment in pts with mCRC. Multivariable analysis shows a significant interaction of treatment with OS. Our finding that the positive effect on survival for maintenance treatment is most pronounced in pts with synchronous disease and resected primary tumor and with PR/CR to induction treatment should be confirmed.

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Final results from NSABP protocol R-04: Neoadjuvant chemoradiation (RT) comparing continuous infusion (CIV) 5-FU with capecitabine (Cape) with or without oxaliplatin (Ox) in patients with stage II and III rectal cancer

Abstract No: 3603
Author(s): Carmen Joseph Allegra, Greg Yothers, Michael J. O'Connell, et al. Conclusions: CVI 5-FU or oral Cape combined with RT produced similar outcomes for L-R control, DFS and OS, and establishes Cape as a standard of care in the pre-op rectal setting. Ox did not improve L-R failure rate, DFS, or OS for any patient risk group but did add significant toxicity. Molecular studies using this fully annotated tissue bank are on-going.

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Four-year survival in patients (pts) undergoing liver surgery after neoadjuvant triplet hepatic artery infusion (HAI) and intravenous cetuximab (IV-CET) for previously treated and unresectable liver metastases from kras wt colorectal cancer (LM-CRC) (European trial OPTILIV, NCT00852228)

Abstract No: 3589
Author(s): Francis Levi, Michel Ducreux, Denis Michel Smith, et al. Conclusions: The combination of IV-CET with HAI-IFO deserves upfront evaluation as a most effective neoadjuvant treatment option within a medico-surgical strategy aiming at the eradication of LM-CRC.

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Preoperative chemoradiotherapy and postoperative chemotherapy with 5-fluorouracil and oxaliplatin versus 5-fluorouracil alone in locally advanced rectal cancer: Results of the German CAO/ARO/AIO-04 randomized phase III trial

Abstract No: 3500
Author(s): Claus Rodel, Torsten Liersch, Rainer Fietkau, et al. Conclusions: Adding oxaliplatin to 5-FU-based neoadjuvant CRT and adjuvant chemotherapy in locally advanced rectal cancer significantly improved DFS.

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Second-line therapies in patients with KRAS wild-type metastatic colorectal cancer (mCRC) after first-line therapy with FOLFIRI in combination with cetuximab or bevacizumab in the AIO KRK0306 (FIRE 3) trial

Abstract No: 3558^
Author(s): Dominik Paul Modest, Sebastian Stintzing, Ludwig Fischer Von Weikersthal, et al. Conclusions: This retrospective analysis indicates that second-line application of antibodies was favoured in patients with shorter first-line PFS, suggesting that preplanned second-line therapy may not reflect therapeutic reality. Correspondingly, second-line treatment without antibodies compared to antibody-based regimens was associated with longer OS. A trend towards longer second-line therapy was observed in favour of patients receiving cetuximab as first-line therapy.

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Subgroup analyses in RAS mutant, BRAF mutant and all-wt mCRC pts treated with FOLFOXIRI plus bevacizumab (bev) or FOLFIRI plus bev in the TRIBE study

Abstract No: 3519
Author(s): Fotios Loupakis, Chiara Cremolini, Sara Lonardi, et al. Conclusions: Benefit from FOLFOXIRI plus bev was independent of RAS and BRAF mutational status, with a trend toward a larger benefit in BRAF mut limited by small subgroup size. All wt pts treated with FOLFOXIRI plus bev achieved impressive PFS and OS results. Independently from the treatment received RAS or BRAFmut pts had shorter long-term survival.

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Surgical resection of primary tumors (SRPT) in asymptomatic patients with stage IV colorectal cancer (CRC): A Canadian province experience

Abstract No: 3527
Author(s): Shahid Ahmed, Anthony L.A. Fields, Leis Anne, et al. Conclusions: This first large population based cohort study confirmss that SRPT, improves survival independent of chemotherapy, age, functional status and comorbid illness, in asymptomatic patients with stage IV CRC.

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Treatment outcome according to tumor RAS mutation status in CRYSTAL study patients with metastatic colorectal cancer (mCRC) randomized to FOLFIRI with/without cetuximab

Abstract No: 3506
Author(s): Fortunato Ciardiello, Heinz-Josef Lenz, Claus-Henning Kohne, et al. Conclusions: In the first-line treatment of mCRC, pts with RAS wt tumors derived a marked benefit from the addition of cetuximab to FOLFIRI; pts with RAS tumor mutations did not benefit. This finding may allow the further tailoring of cetuximab therapy to maximize pt benefit.

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Câncer de Canal Anal

A comparison between 5-fluorouracil/mitomycin (FM) and capecitabine/mitomycin (CM) in combination with radiation (RT) for squamous cell carcinoma (SCC) of the anal canal

Abstract No: 4031
Author(s): Dante D.C. Wan, Devin Schellenberg, John Hay, et al. Conclusions: There is no difference between the two cohorts in this retrospective study. Additionally, there is a trend towards lower recurrence rates favoring capecitabine that may be explored in larger phase III studies. Capecitabine can be considered an alternative to 5FU in the chemoradiation treatment of SCC of the anus.

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Cancer de Esôfago

Chemoradiation with or without nimotuzumab in locally advanced esophageal cancer (LAEC): A randomized phase II study (NICE trial)

Abstract No: 4078
Author(s): Gilberto Castro, Nils G Skare, Carlos J C Andrade, et al. Conclusions: Combined chemoradiation and nimotuzumab is safe in pts with LAEC, and appears to increase the combined eCR/pCR rate and to impact favorably on OS. This is a promising regimen in pts with locally advanced esophageal SCC, and a phase III trial is under consideration.

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HER-FLOT: Trastuzumab in combination with FLOT as perioperative treatment for patients with HER2-positive locally advanced esophagogastric adenocarcinoma: A phase II trial of the AIO Gastric Cancer Study Group

Abstract No: 4073^
Author(s): Ralf Hofheinz, Susanna Hegewisch-Becker, Peter C. Thuss-Patience, et al. Conclusions: HER-FLOT was found to be safe and no new or unexpected safety issues were noticed. Preliminary data on centrally assessed pCR rate is very promising with >20% achieving a pCR. Final analysis will be presented at the meeting.

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RTOG 0436: A phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin, and radiation for patients with esophageal cancer treated without surgery

Abstract No: 4007
Author(s): David H. Ilson, Jennifer Moughan, Mohan Suntharalingam, et al. Conclusions: Cetuximab added to chemoradiation did not improve OS. There were no differences in cCR rates by tx arm. These results add to the growing body of literature indicating no benefit for current EGFR targeted agents in the tx of unselected patients with EC.

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Hepatocarcinoma

A phase II study of temsirolimus in previously treated advanced hepatocellular carcinoma (HCC)

Abstract No: 4098
Author(s): Jasgit C. Sachdev, Ahmed Y Javed, Alva Bowen Weir, et al. Conclusions: T showed higher responses than previously reported with systemic Rx for HCC. The primary end point was met with >1/2 of the Pts progression free at 3 months, and >1/3 at 6 months. We speculate that IV administration may have overcome compliance issues in drug administration, favorably impacting efficacy, as reflected by the response rates in this study, in contrast with those reported with the oral mTORi.

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A phase II trial of second-line axitinib following prior antiangiogenic therapy in advanced hepatocellular carcinoma (HCC)

Abstract No: 4092
Author(s): Mairead Geraldine McNamara, Lisa W Le, Anne M Horgan, et al. Conclusions: With 42% tumor control at 16 wks, primary endpoint was met.Axitinib has shown encouraging tolerable clinical activity in this VEGF pretreated HCC pt population and warrants further study incorporating potential biomarkers of response.

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Phase 3 randomized, double-blind, controlled study of cabozantinib (XL184) versus placebo in subjects with hepatocellular carcinoma who have received prior sorafenib (CELESTIAL; NCT01908426)

Abstract No: TPS4150
Author(s): Ghassan K. Abou-Alfa, Ann-Lii Cheng, Tim Meyer, et al.
This phase 3, randomized, double-blind study evaluates the efficacy and safety of cabozantinib compared with placebo in subjects with advanced HCC previously treated with sorafenib and have progressed following 1-2 prior systemic treatments for HCC. The primary endpoint is overall survival. Secondary endpoints are progression-free survival and objective response rate by RECIST 1.1.
The full, final text of this abstract will be posted online

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RESORCE: An ongoing randomized, double-blind, phase III trial of regorafenib (REG) in patients with hepatocellular carcinoma (HCC) progressing on sorafenib (SOR)

Abstract No: TPS4156^
Author(s): Jordi Bruix, Richard S. Finn, Masatoshi Kudo, Josep M. Llovet, et al.
This randomized, double-blind, placebo (Pbo)-controlled, multinational study (ClinicalTrials.gov identifier NCT01774344) will compare the efficacy and tolerability of REG vs Pbo in adults with HCC that has progressed on SOR. The primary endpoint is OS; secondary endpoints are TTP, progression-free survival, objective tumor response, disease control, and safety. As of February 2014, 137 out of the planned 530 patients have been randomized. The full, final text of this abstract will be posted online

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Tumores de Via Biliar

Second-line chemotherapy for advanced biliary tract cancer after failure of gemcitabine plus platinum: Results of an AGEO multicenter retrospective study

Abstract No: 4093
Author(s): Bertrand Brieau, Laetitia Dahan, Yann De Rycke, et al. Conclusions: CT2 is associated with a disease control in a half of pts with ABTC who received gem-platinum in CT1. Nevertheless, the short median PFS observed in this study should encourage the evaluation of new treatments in pts with good clinical conditions and an adequate biliary drainage.

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Câncer de Pâncreas

APACT: A phase 3 randomized, open-label, multicenter trial evaluating the use of adjuvant nab-paclitaxel (nab-P) plus gemcitabine (G) versus G alone in patients (pts) with surgically resected ductal pancreatic adenocarcinoma (PDA)

Abstract No: TPS4162^
Author(s): Margaret A. Tempero, Dana Backlund Cardin, Andrew Biankin, et al. Approximately 800 eligible pts will be randomized 1:1 (stratified by resection status [R0 vs R1], lymph node status [positive vs negative], and region) to receive nab-P 125 mg/m2 plus G 1000 mg/m2 or G 1000 mg/m2 on days 1, 8, and 15 of a 28-day cycle for 6 cycles. The primary endpoint is DFS by independent review. Secondary endpoints include: OS and safety. Exploratory endpoints include tumor markers and quality of life by EORTC QLQ-C30 and QLQ-PAN26. One interim analysis for safety and 2 interim analyses for efficacy are planned. This design provides 90% power to detect a hazard ratio of 0.74 for DFS, with a 2-sided 5% significance level, which represents a 36% improvement in median DFS with nab-P plus G vs G alone.

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Impact of gemcitabine (Gem)- or capecitabine (Cape)-based chemoradiation (CRT) on health-relatedquality of life (HRQL) in patients with locally advanced pancreatic cancer (LAPC): Outcomes from the randomized phase II SCALOP trial

Abstract No: 4126
Author(s): Somnath Mukherjee, Chris Hurt, Peter Dutton, et al.
The better HRQL in the Cape-CRT arm complements the outcome from the main trial and further supports the use of Cape rather than Gem as concomitant chemotherapy with radiation in LAPC.

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PANCREOX: A randomized phase 3 study of 5FU/LV with or without oxaliplatin for second-line advanced pancreatic cancer (APC) in patients (pts) who have received gemcitabine (GEM)-based chemotherapy (CT)

Abstract No: 4022
Author(s): Sharlene Gill, Yoo-Joung Ko, M. Christine Cripps, etl a. Conclusions: No benefit was observed with the addition of oxaliplatin to infusional 5FU/LV in GEM-treated 2nd line APC. PFS was similar and OS was inferior with mFOLFOX6. Given the proven benefit of FOLFIRINOX in untreated APC (ACCORD 11), these results suggest that the opportunity for use of oxaliplatin-based CT would be primarily in the 1st-line setting.

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