Volume 77, Issue 4 pp. 247-252

A PILOT STUDY OF PREOPERATIVE AND POSTOPERATIVE CHEMOTHERAPY IN PATIENTS WITH OPERABLE GASTRIC CANCER: AUSTRALASIAN GASTROINTESTINAL TRIALS GROUP STUDY 9601

Michael Findlay

Corresponding Author

Michael Findlay

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

Professor Michael Findlay, c/- AGITG Coordinating Centre, NHMRC Clinical Trials Centre, Locked Bag 77, Camperdown, NSW 1450, Australia.
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David Storey

David Storey

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Val Gebski

Val Gebski

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Carol Hargreaves

Carol Hargreaves

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Graham Cullingford

Graham Cullingford

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Michael Boyer

Michael Boyer

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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James Trotter

James Trotter

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Stephen Archer

Stephen Archer

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Andrew Davidson

Andrew Davidson

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Peter Johnston

Peter Johnston

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Jennifer Yuen

Jennifer Yuen

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Haryana Dhillon

Haryana Dhillon

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Stephen Della-Fiorentina

Stephen Della-Fiorentina

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Gary Richardson

Gary Richardson

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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Philip Truskett

Philip Truskett

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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David Goldstein

David Goldstein

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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The AGITG

The AGITG

* Wellington Cancer Centre and †† Department of Surgery, Wellington Hospital, Wellington, New Zealand ; Sydney Cancer Centre, Royal Prince Alfred Hospital , NHMRC Clinical Trials Centre, University of Sydney , ‡‡ Cancer Therapy Centre, Liverpool Hospital and ¶¶ Department of Surgery and *** Institute of Oncology, Prince of Wales Hospital, Sydney, New South Wales , and § Department of Surgery, Fremantle Hospital , and Department of Medical Oncology and ** Department of Surgery, Royal Perth Hospital, Perth, Western Australia , and §§ Cabrini Oncology, Cabrini Hospital, Melbourne, Victoria, Australia

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First published: 27 March 2007
Citations: 3

Australasian Gastrointestinal Trials Group (AGITG): Trial Management Committee: Professor Michael Findlay, Dr David Storey, Associate Professor Val Gebski, Dr Jeremy Simpson, Ms Jenny Yuen, Ms Haryana Dhillon. Trial Coordinating and Data Centre: NHMRC Clinical Trials Centre, J. Yuen, H. Dhillon, V. Gebski, R. J. Simes, M. Stockler, L. Tyndall. Programming: Y. Baik. Participating investigators: M. Boyer, M. Findlay, D. Storey, Royal Prince Alfred Hospital; S. Clarke, Concord General Hospital; D. Goldstein, Prince of Wales Hospital; E. Walpole, B. M. Smithers, D. Thomson, Princess Alexandra Hospital; G. Cullingford, A. Davidson, Fremantle Hospital; S. Archer, E. Bayliss, A. Chan, D. Ransom, J. Trotter, Royal Perth Hospital; G. Richardson, Monash Medical Centre; S. Della-Fiorentina, E. Moylan, Liverpool Hospital; G. van Hazel, The Mount Hospital; M. Findlay, P. Dady, P. Johnston, Wellington Cancer Centre. Participating centre research staff: E. Emmett, R. Roberts, Royal Prince Alfred Hospital; L. Truong, Concord General Hospital; K. MacDonald, Prince of Wales Hospital; D. Jackson, S. Ivanhoe, Princess Alexandra Hospital; C. Randell, Fremantle Hospital; L. Donleavy, C. Stone, Z. Bradfield, Royal Perth Hospital; B. Scher, L. Muceniekas, Monash Medical Centre; D. Burns, S. Taufa, Liverpool Hospital; A. Provis, The Mount Hospital; B. Markham, P. Morum, Wellington Cancer Centre.

Abstract

Background:  With poor cure rates in gastric cancer using surgery alone, the safety, efficacy and feasibility of preoperative and postoperative chemotherapy was investigated.

Methods:  Patients with advanced but operable gastric or cardio-oesophageal adenocarcinoma were staged using endoscopy, computed tomography scan and laparoscopy. If considered potentially resectable, they received chemotherapy (epirubicin, cisplatin and 5-fluorouracil) for 9 weeks before and after surgery.

Results:  Of 59 participants entered, two were found to have metastatic disease and were excluded from the analysis. Of the participants, 10 were women and 47 men; their median age was 58 years (range 27–83 years) and median performance status 0 (range 0–1). Two of the 57 participants commencing chemotherapy did not undergo surgery (one sudden death, one new liver metastases). Grade 3 and 4 preoperative and postoperative toxicity rates were, respectively, neutropenia 22 and 18%, emesis 12 and 14% and other non-haematological toxicity <10 and <10%. Of the 55 who underwent surgery, 40 had apparently curative resections (clear or positive microscopic margins), 2 died after surgery (anastomotic leak, sepsis) and 16 had postoperative complications. Of these, 27 participants commenced postoperative chemotherapy and 21 completed it. Median progression-free survival and overall survival were 19.6 and 22 months, respectively.

Conclusion:  Epirubicin, cisplatin and protracted venous infusion of 5-fluorouracil chemotherapy was well-tolerated in the preoperative setting and did not appear to increase complication rates of surgery for advanced and operable stomach cancer. These findings demonstrate the feasibility of this strategy in the Australasian clinical setting and are in keeping with the results of a recently reported randomized trial, which demonstrated a significant survival advantage using this chemotherapy regimen.

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