Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02)

Ruhstaller, Thomas; Widmer, Lucas; Schuller, Jan C.; Roth, Arnaud; Hess, V.; Mingrone, Walter; Moos, Roger von; Borner, Markus; Paulweber, Bernhard; Balmer-Majno, S.; Köberle, Dieter; Terraciano, L.; Schnider, Armin; Bodis, Stephan; Popescu, Răzvan

doi:10.1093/annonc/mdp045

Cited by 72 publications

(63 citation statements)

References 25 publications

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“…Toxicities from these new combinations are acceptable and early results are promising. Induction docetaxel/cisplatin followed by the same regimen with radiation and then surgery reported a pCR (or near) rate of 47%, with survival data similar to other phase II studies [Ruhstaller et al 2009;Schuller et al 2008].…”

Section: Neo-adjuvant Chemoradiotherapysupporting

confidence: 80%

Review: Integration of targeted agents in the neo-adjuvant treatment of gastro-esophageal cancers

Power

Ilson

2009

Ther Adv Med Oncol

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Pre-and peri-operative strategies are becoming standard for the management of localized gastro-esophageal cancer. For localized gastric/gastro-esophageal junction (GEJ) cancer there are conflicting data that a peri-operative approach with cisplatin-based chemotherapy improves survival, with the benefits seen in esophageal cancer likely less than a 510% incremental improvement. Further trends toward improvement in local control and survival, when combined chemotherapy and radiation therapy are given pre-operatively, are suggested by recent phase III trials. In fit patients, a significant survival benefit with pre-operative chemoradiation is seen in those patients who achieve a pathologic complete response. In esophageal/GEJ cancer, definitive chemoradiation is now considered in medically inoperable patients. In squamous cell carcinoma of the esophagus, surgery after primary chemoradiation is not clearly associated with an improved overall survival, however, local control may be better. In localized gastric/GEJ cancer, the integration of bevacizumab with pre-operative chemotherapy is being explored in large randomized studies, and with chemoradiotherapy in pilot trials. The addition of anti-epidermal growth factor receptor and anti-human epidermal growth factor receptor-2 antibody treatment to pre-operative chemoradiation continues to be explored. Early results show the integration of targeted therapy is feasible. Metabolic imaging can predict early response to pre-operative chemotherapy and biomarkers may further predict response to pre-operative chemo-targeted therapy. A multimodality approach to localized gastro-esophageal cancer has resulted in better outcomes. For T3 or node-positive disease, surgery alone is no longer considered appropriate and neo-adjuvant therapy is recommended. The future of neo-adjuvant strategies in this disease will involve the individualization of therapy with the integration of molecular signatures, targeted therapy, metabolic imaging and predictive biomarkers.

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Section: Neo-adjuvant Chemoradiotherapysupporting

confidence: 80%

Review: Integration of targeted agents in the neo-adjuvant treatment of gastro-esophageal cancers

Power

Ilson

2009

Ther Adv Med Oncol

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“…[147][148][149][150][151][152][153][154][155][156][157][158][159][160][161][162][163] In a recent phase I/II study, preoperative chemoradiation with a three drug regimen comprising of docetaxel, oxaliplatin, and capecitabine was safe and effective in patients with locoregional disease. 164 At a median follow-up of 116 weeks, median disease-free and overall survivals were 16 and 24 months, respectively.…”

Section: Preoperative Chemoradiation Therapymentioning

confidence: 99%

Esophageal and Esophagogastric Junction Cancers

Ajani¹,

Barthel²,

Bentrem³

et al. 2011

J Natl Compr Canc Netw

205

153

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“…PET imaging was performed as part of a prospective multi-center phase II trial investigating a cisplatin-and taxane-based regimen of 2 cycles of inductionchemotherapy,followedbyCRTandsurgery(SwissGroupfor ClinicalCancerResearch,SAKK75/02,NCT00072033) [17].Theprotocol wasapprovedbythelocalethicscommitteesoftheparticipatingcenters. ThestudypopulationconsistedofpreviouslyuntreatedpatientswithhistologicallyconfirmedlocallyadvancedbutresectableSCCandadenocarcinomaofthethoracicesophagusoresophagogastricjunctionclassifiedasclinicalstageT3N0,T1-3N+orT4Nx,accordingtotheAJCCCancerStaging Manual, 6th edition [18].…”

Section: Patientsmentioning

confidence: 99%

Limited Predictive Value of FDG-PET for Response Assessment in the Preoperative Treatment of Esophageal Cancer: Results of a Prospective Multi-Center Trial (SAKK 75/02)

Klaeser

Nitzsche²,

Schuller³

et al. 2009

Onkologie

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SummaryBackground: Only responding patients benefit from preoperative therapy for locally advanced esophageal carcinoma. Early detection of non-responders may avoid futile treatment and delayed surgery. Patients and Methods: In a multi-center phase ll trial, patients with resectable, locally advanced esophageal carcinoma were treated with 2 cycles of induction chemotherapy followed by chemoradiotherapy (CRT) and surgery. Positron emission tomography with 2-[fluorine-18]fluoro-2-deoxy-d-glucose (FDG-PET) was performed at baseline and after induction chemotherapy. The metabolic response was correlated with tumor regression grade (TRG). A decrease in FDG tumor uptake of less than 40% was prospectively hypothesized as a predictor for histopathological non-response (TRG > 2) after CRT. Results: 45 patients were included. The median decrease in FDG tumor uptake after chemotherapy correlated well with TRG after completion of CRT (p = 0.021). For an individual patient, less than 40% decrease in FDG tumor uptake after induction chemotherapy predicted histopathological non-response after completion of CRT, with a sensitivity of 68% and a specificity of 52% (positive predictive value 58%, negative predictive value 63%). Conclusions: Metabolic response correlated with histopathology after preoperative therapy. However, FDG-PET did not predict non-response after induction chemotherapy with sufficient clinical accuracy to justify withdrawal of subsequent CRT and selection of patients to proceed directly to surgery. 18 F]Fluor-2-desoxy-d-glukose (FDG-PET) wurde vor Therapiebeginn und nach Abschluss der Induktionschemotherapie durchgeführt. Das metabolische Ansprechen wurde mit dem Tumorregressionsgrad (TRG) korreliert. Die Hypothese, dass weniger als 40% Abnahme des Wertes der FDG-Aufnahme ein früher prädiktiver Parameter für das Nichtansprechen sei (TRG > 2), wurde prospektiv geprüft. Ergebnisse: 45 Patienten wurden eingeschlossen. Die mittlere Abnahme der FDG-Anreicherung im Tumor korrelierte gut mit dem TRG nach Abschluss der CRT (p = 0,021). Eine Abnahme der FDG-Anreicherung von weniger als 40% sagte ein Nichtansprechen mit einer Sensitivität von 68% und einer Spezifität von 52% voraus (positiver Vorhersagewert 58%, negativer Vorhersagewert 63%). Schlussfolgerungen: Das metabolische Ansprechen nach präoperativer Therapie korrelierte insgesamt gut mit dem histopathologischen Ansprechen. Die FDG-PET sagte jedoch das Nichtansprechen im individuellen Fall nicht mit ausreichender Sicherheit voraus, um den vorzeitigen Abbruch der CRT und eine direkte Operation zu rechtfertigen.

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Multicenter phase II trial of preoperative induction chemotherapy followed by chemoradiation with docetaxel and cisplatin for locally advanced esophageal carcinoma (SAKK 75/02)

Abstract: This neoadjuvant, taxane-containing regimen was efficacious and feasible in patients with locally advanced esophageal cancer in a multicenter, community-based setting and represents a suitable backbone for further investigation.

Cited by 72 publications

References 25 publications

Review: Integration of targeted agents in the neo-adjuvant treatment of gastro-esophageal cancers

Review: Integration of targeted agents in the neo-adjuvant treatment of gastro-esophageal cancers

Esophageal and Esophagogastric Junction Cancers

Limited Predictive Value of FDG-PET for Response Assessment in the Preoperative Treatment of Esophageal Cancer: Results of a Prospective Multi-Center Trial (SAKK 75/02)

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