Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial
Salah-Eddin Al-Batran,Nils Homann,Claudia Pauligk,Gerald Illerhaus,Uwe M. Martens,Jan Stoehlmacher,Harald Schmalenberg,Kim Barbara Luley,Nicole Prasnikar,Matthias Egger,Stephan Probst,Helmut Messmann,Markus Moehler,Wolfgang Fischbach,Jörg T. Hartmann,Frank Mayer,Heinz-Gert Höffkes,Michael Koenigsmann,Dirk Arnold,Thomas Kraus,Kersten Grimm,Stefan Berkhoff,Stefan Post,Elke Jäger,Wolf O. Bechstein,Ulrich Ronellenfitsch,Stefan Mönig,Ralf Hofheinz +27 more
Reads0
Chats0
TLDR
Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival, and the AIO-FLOT3 trial provides a rationale for further randomized clinical trials.Abstract:
Importance Surgical resection has a potential benefit for patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. Objective To evaluate outcome in patients with limited metastatic disease who receive chemotherapy first and proceed to surgical resection. Design, Setting, and Participants The AIO-FLOT3 (Arbeitsgemeinschaft Internistische Onkologie–fluorouracil, leucovorin, oxaliplatin, and docetaxel) trial is a prospective, phase 2 trial of 252 patients with resectable or metastatic gastric or gastroesophageal junction adenocarcinoma. Patients were enrolled from 52 cancer care centers in Germany between February 1, 2009, and January 31, 2010, and stratified to 1 of 3 groups: resectable (arm A), limited metastatic (arm B), or extensive metastatic (arm C). Data cutoff was January 2012, and the analysis was performed in March 2013. Interventions Patients in arm A received 4 preoperative cycles of fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) followed by surgery and 4 postoperative cycles. Patients in arm B received at least 4 cycles of neoadjuvant FLOT and proceeded to surgical resection if restaging (using computed tomography and magnetic resonance imaging) showed a chance of margin-free (R0) resection of the primary tumor and at least a macroscopic complete resection of the metastatic lesions. Patients in arm C were offered FLOT chemotherapy and surgery only if required for palliation. Patients received a median (range) of 8 (1-15) cycles of FLOT. Main Outcomes and Measures The primary end point was overall survival. Results In total, 238 of 252 patients (94.4%) were eligible to participate. The median (range) age of participants was 66 (36-79) years in arm A (n = 51), 63 (28-79) years in arm B (n = 60), and 65 (23-83) years in arm C (n = 127). Patients in arm B (n = 60) had only retroperitoneal lymph node involvement (27 patients [45%]), liver involvement (11 [18.3%]), lung involvement (10 [16.7%]), localized peritoneal involvement (4 [6.7%]), or other (8 [13.3%]) incurable sites. Median overall survival was 22.9 months (95% CI, 16.5 to upper level not achieved) for arm B, compared with 10.7 months (95% CI, 9.1-12.8) for arm C (hazard ratio, 0.37; 95% CI, 0.25-0.55) ( P Conclusions and Relevance Patients with limited metastatic disease who received neoadjuvant chemotherapy and proceeded to surgery showed a favorable survival. The AIO-FLOT3 trial provides a rationale for further randomized clinical trials. Trial Registration clinicaltrials.gov identifier:NCT00849615read more
Citations
More filters
Journal ArticleDOI
Low level of microsatellite instability correlates with short disease-free survival of gastric cancer patients undergoing neoadjuvant chemotherapy
Dan Jiang,Chang Shu,Wei-Han Zhang,Linyong Sun,Mengni Zhang,Yanjun He,Gemma Owen,Wanjun Jin,Du He,Xiangbing Deng,Xiaoyu Liu +10 more
TL;DR: MSI-L is an independent poor prognostic biomarker for the locally advanced gastric cancer treated with neoadjuvant chemotherapy and is correlated with perineural invasion and decreased MUC5AC expression.
Journal ArticleDOI
Treatment Strategy for Oligometastatic Gastric Cancer: Brief Considerations
TL;DR: This study was for exploratory purposes and, given the lack of randomization, did not provide a real estimate of the benefit of surgery compared to chemotherapy alone, so the RENAISSANCE trial is expected to clarify the role of surgery in the treatment strategy of oligometastatic disease.
Journal ArticleDOI
Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Chemotherapy With and Without Sequential Cytoreductive Interventions for Patients with Oligometastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Levels
Ankit Dhiman,Charles C. Vining,Hunter Witmer,Divya Sood,Ardaman Shergill,Hedy L. Kindler,Kevin K. Roggin,Mitchell C. Posner,Osmanuddin Ahmed,Stanley L. Liauw,Sean P. Pitroda,Chih-Yi Liao,Theodore Karrison,Ralph R. Weichselbaum,Blase N. Polite,Oliver S. Eng,Daniel V.T. Catenacci,Kiran K. Turaga +17 more
TL;DR: In this article , the role of sequential cytoreductive interventions in addition to the standard of care chemotherapy in patients with oligometastatic foregut adenocarcinoma was investigated.
Journal ArticleDOI
Analysis of treatment outcomes according to the cycles of adjuvant chemotherapy in gastric cancer: a retrospective nationwide cohort study
Tae-Hwan Kim,Mi Sun Ahn,Yong Won Choi,Seok Yun Kang,Jin-Hyuk Choi,Hyun Woo Lee,Mi Jin Park,Hasung Kim +7 more
TL;DR: In this paper , the authors investigated outcomes according to the cycles of adjuvant chemotherapy, using data from the Korean Health Insurance and Assessment Service, and evaluated the five-year overall survival rate.
References
More filters
Journal ArticleDOI
New Guidelines to Evaluate the Response to Treatment in Solid Tumors
Patrick Therasse,Susan G. Arbuck,Elizabeth Eisenhauer,Jantien Wanders,Richard Kaplan,Larry Rubinstein,Jaap Verweij,Martine Van Glabbeke,Allan T. van Oosterom,Michaele C. Christian,S. Gwyther +10 more
TL;DR: A model by which a combined assessment of all existing lesions, characterized by target lesions and nontarget lesions, is used to extrapolate an overall response to treatment is proposed, which is largely validated by the Response Evaluation Criteria in Solid Tumors Group and integrated into the present guidelines.
Journal ArticleDOI
New guidelines to evaluate the response to treatment in solid tumors
Patrick Therasse,Susan G. Arbuck,Elizabeth Eisenhauer,Jantien Wanders,Richard Kaplan,Larry Rubinstein,Jaap Verweij,Martine Van Glabbeke,Allan T. van Oosterom,Michaele C. Christian,S. Gwyther +10 more
TL;DR: In this article, the authors proposed a model by which a combined assessment of all existing lesions, characterized by target lesions (to be measured) and nontarget lesions, is used to extrapolate an overall response to treatment.
Journal ArticleDOI
Histopathological regression after neoadjuvant docetaxel, oxaliplatin, fluorouracil, and leucovorin versus epirubicin, cisplatin, and fluorouracil or capecitabine in patients with resectable gastric or gastro-oesophageal junction adenocarcinoma (FLOT4-AIO): results from the phase 2 part of a multicentre, open-label, randomised phase 2/3 trial.
Salah-Eddin Al-Batran,Ralf Hofheinz,Claudia Pauligk,Hans-Georg Kopp,Georg Martin Haag,Kim Barbara Luley,Johannes Meiler,Nils Homann,Sylvie Lorenzen,Harald Schmalenberg,Stephan Probst,Michael Koenigsmann,Matthias Egger,Nicole Prasnikar,Karel Caca,Jörg Trojan,Uwe M. Martens,Andreas Block,Wolfgang Fischbach,Rolf Mahlberg,Michael R. Clemens,Gerald Illerhaus,Katja Zirlik,Dirk Behringer,Wolff Schmiegel,Michael Pohl,Michael Heike,Ulrich Ronellenfitsch,Martin Schuler,Wolf O. Bechstein,Alfred Königsrainer,Timo Gaiser,Peter Schirmacher,Wael Hozaeel,Alexander Reichart,Thorsten Oliver Goetze,Mark Sievert,Elke Jäger,Stefan Mönig,Andrea Tannapfel +39 more
TL;DR: Findings from the phase 2 part of the FLOT4 trial, which compared histopathological regression in patients treated with a docetaxel-based triplet chemotherapy versus an anthracycline-based doublet chemotherapy before surgical resection, suggest FLOT was associated with significantly higher proportions of patients achieving pathological complete regression than was ECF/ECX.
Journal ArticleDOI
Gastrectomy plus chemotherapy versus chemotherapy alone for advanced gastric cancer with a single non-curable factor (REGATTA): a phase 3, randomised controlled trial
Kazumasa Fujitani,Han-Kwang Yang,Junki Mizusawa,Young-Woo Kim,Masanori Terashima,Sang-Uk Han,Yoshiaki Iwasaki,Woo Jin Hyung,Akinori Takagane,Do Joong Park,Takaki Yoshikawa,Seokyung Hahn,Kenichi Nakamura,Cho Hyun Park,Yukinori Kurokawa,Yung-Jue Bang,Byung Joo Park,Mitsuru Sasako,Toshimasa Tsujinaka +18 more
TL;DR: Since gast rectomy followed by chemotherapy did not show any survival benefit compared with chemotherapy alone in advanced gastric cancer with a single non-curable factor, gastrectomy cannot be justified for treatment of patients with these tumours.
Journal ArticleDOI
Value of palliative resection in gastric cancer.
TL;DR: Non‐curatively treated patients from the Dutch Gastric Cancer Trial were studied to define more accurately which patients might benefit from palliative resection.