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Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial

Summary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction sh... Full description

Journal Title: The lancet oncology 2015, Vol.16 (9), p.1090-1098
Main Author: Shapiro, Joel, Dr
Other Authors: van Lanschot, J Jan B, Prof , Hulshof, Maarten C C M, MD , van Hagen, Pieter, MD , van Berge Henegouwen, Mark I, MD , Wijnhoven, Bas P L, MD , van Laarhoven, Hanneke W M, Prof , Nieuwenhuijzen, Grard A P, MD , Hospers, Geke A P, Prof , Bonenkamp, Johannes J, MD , Cuesta, Miguel A, Prof , Blaisse, Reinoud J B, MD , Busch, Olivier R C, Prof , ten Kate, Fiebo J W, Prof , Creemers, Geert-Jan M, MD , Punt, Cornelis J A, Prof , Plukker, John Th M, Prof , Verheul, Henk M W, Prof , Bilgen, Ernst J Spillenaar, MD , van Dekken, Herman, MD , van der Sangen, Maurice J C, MD , Rozema, Tom, MD , Biermann, Katharina, MD , Beukema, Jannet C, MD , Piet, Anna H M, MD , van Rij, Caroline M, MD , Reinders, Janny G, MD , Tilanus, Hugo W, Prof , Steyerberg, Ewout W, Prof , van der Gaast, Ate, MD
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/26254683
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title: Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial
format: Article
creator:
  • Shapiro, Joel, Dr
  • van Lanschot, J Jan B, Prof
  • Hulshof, Maarten C C M, MD
  • van Hagen, Pieter, MD
  • van Berge Henegouwen, Mark I, MD
  • Wijnhoven, Bas P L, MD
  • van Laarhoven, Hanneke W M, Prof
  • Nieuwenhuijzen, Grard A P, MD
  • Hospers, Geke A P, Prof
  • Bonenkamp, Johannes J, MD
  • Cuesta, Miguel A, Prof
  • Blaisse, Reinoud J B, MD
  • Busch, Olivier R C, Prof
  • ten Kate, Fiebo J W, Prof
  • Creemers, Geert-Jan M, MD
  • Punt, Cornelis J A, Prof
  • Plukker, John Th M, Prof
  • Verheul, Henk M W, Prof
  • Bilgen, Ernst J Spillenaar, MD
  • van Dekken, Herman, MD
  • van der Sangen, Maurice J C, MD
  • Rozema, Tom, MD
  • Biermann, Katharina, MD
  • Beukema, Jannet C, MD
  • Piet, Anna H M, MD
  • van Rij, Caroline M, MD
  • Reinders, Janny G, MD
  • Tilanus, Hugo W, Prof
  • Steyerberg, Ewout W, Prof
  • van der Gaast, Ate, MD
subjects:
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Cancer therapies
  • Carboplatin - administration & dosage
  • Cervical cancer
  • Chemoradiotherapy
  • Chemotherapy
  • Disease-Free Survival
  • Endoscopy
  • Esophageal cancer
  • Esophageal Neoplasms - drug therapy
  • Esophageal Neoplasms - pathology
  • Esophageal Neoplasms - radiotherapy
  • Esophageal Neoplasms - surgery
  • Esophagogastric Junction - drug effects
  • Esophagogastric Junction - pathology
  • Esophagogastric Junction - radiation effects
  • Esophagogastric Junction - surgery
  • Female
  • Fluorouracil - administration & dosage
  • Hematology, Oncology and Palliative Medicine
  • Histology
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Mortality
  • Neoplasm Staging
  • Paclitaxel - administration & dosage
  • Radiation therapy
  • Squamous cell carcinoma
  • Surgery
  • Ultrasonic imaging
ispartof: The lancet oncology, 2015, Vol.16 (9), p.1090-1098
description: Summary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months' follow-up. In this Article, we report the long-term results after a minimum follow-up of 5 years. Methods Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2–3N0–1M0, according to the TNM cancer staging system, sixth edition) were randomly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by surgery, or surgery alone. The primary endpoint was overall survival, analysed by intention-to-treat. No adverse event data were collected beyond those noted in the initial report of the trial. This trial is registered with the Netherlands Trial Register, number NTR487, and has been completed. Findings Between March 30, 2004, and Dec 2, 2008, 368 patients from eight participating centres (five academic centres and three large non-academic teaching hospitals) in the Netherlands were enrolled into this study and randomly assigned to the two treatment groups: 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone. Two patients in the neoadjuvant chemoradiotherapy group withdrew consent, so a total of 366 patients were analysed (178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group). Of 171 patients who received any neoadjuvant chemoradiotherapy in this group, 162 (95%) were able to complete the entire neoadjuvant chemoradiotherapy regimen. After a median follow-up for surviving patients of 84·1 months (range 61·1–116·8, IQR 70·7–96·6), median overall survival was 48·6 months (95% CI 32·1–65·1) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months (14·2–33·7) in the surgery alone group (HR 0·68 [95% CI 0·53–0·88]; log-rank p=0·003). Median overall survival for
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleNeoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial
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creatorShapiro, Joel, Dr ; van Lanschot, J Jan B, Prof ; Hulshof, Maarten C C M, MD ; van Hagen, Pieter, MD ; van Berge Henegouwen, Mark I, MD ; Wijnhoven, Bas P L, MD ; van Laarhoven, Hanneke W M, Prof ; Nieuwenhuijzen, Grard A P, MD ; Hospers, Geke A P, Prof ; Bonenkamp, Johannes J, MD ; Cuesta, Miguel A, Prof ; Blaisse, Reinoud J B, MD ; Busch, Olivier R C, Prof ; ten Kate, Fiebo J W, Prof ; Creemers, Geert-Jan M, MD ; Punt, Cornelis J A, Prof ; Plukker, John Th M, Prof ; Verheul, Henk M W, Prof ; Bilgen, Ernst J Spillenaar, MD ; van Dekken, Herman, MD ; van der Sangen, Maurice J C, MD ; Rozema, Tom, MD ; Biermann, Katharina, MD ; Beukema, Jannet C, MD ; Piet, Anna H M, MD ; van Rij, Caroline M, MD ; Reinders, Janny G, MD ; Tilanus, Hugo W, Prof ; Steyerberg, Ewout W, Prof ; van der Gaast, Ate, MD
creatorcontribShapiro, Joel, Dr ; van Lanschot, J Jan B, Prof ; Hulshof, Maarten C C M, MD ; van Hagen, Pieter, MD ; van Berge Henegouwen, Mark I, MD ; Wijnhoven, Bas P L, MD ; van Laarhoven, Hanneke W M, Prof ; Nieuwenhuijzen, Grard A P, MD ; Hospers, Geke A P, Prof ; Bonenkamp, Johannes J, MD ; Cuesta, Miguel A, Prof ; Blaisse, Reinoud J B, MD ; Busch, Olivier R C, Prof ; ten Kate, Fiebo J W, Prof ; Creemers, Geert-Jan M, MD ; Punt, Cornelis J A, Prof ; Plukker, John Th M, Prof ; Verheul, Henk M W, Prof ; Bilgen, Ernst J Spillenaar, MD ; van Dekken, Herman, MD ; van der Sangen, Maurice J C, MD ; Rozema, Tom, MD ; Biermann, Katharina, MD ; Beukema, Jannet C, MD ; Piet, Anna H M, MD ; van Rij, Caroline M, MD ; Reinders, Janny G, MD ; Tilanus, Hugo W, Prof ; Steyerberg, Ewout W, Prof ; van der Gaast, Ate, MD ; CROSS study group
descriptionSummary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months' follow-up. In this Article, we report the long-term results after a minimum follow-up of 5 years. Methods Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2–3N0–1M0, according to the TNM cancer staging system, sixth edition) were randomly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by surgery, or surgery alone. The primary endpoint was overall survival, analysed by intention-to-treat. No adverse event data were collected beyond those noted in the initial report of the trial. This trial is registered with the Netherlands Trial Register, number NTR487, and has been completed. Findings Between March 30, 2004, and Dec 2, 2008, 368 patients from eight participating centres (five academic centres and three large non-academic teaching hospitals) in the Netherlands were enrolled into this study and randomly assigned to the two treatment groups: 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone. Two patients in the neoadjuvant chemoradiotherapy group withdrew consent, so a total of 366 patients were analysed (178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group). Of 171 patients who received any neoadjuvant chemoradiotherapy in this group, 162 (95%) were able to complete the entire neoadjuvant chemoradiotherapy regimen. After a median follow-up for surviving patients of 84·1 months (range 61·1–116·8, IQR 70·7–96·6), median overall survival was 48·6 months (95% CI 32·1–65·1) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months (14·2–33·7) in the surgery alone group (HR 0·68 [95% CI 0·53–0·88]; log-rank p=0·003). Median overall survival for patients with squamous cell carcinomas was 81·6 months (95% CI 47·2–116·0) in the neoadjuvant chemoradiotherapy plus surgery group and 21·1 months (15·4–26·7) in the surgery alone group (HR 0·48 [95% CI 0·28–0·83]; log-rank p=0·008); for patients with adenocarcinomas, it was 43·2 months (24·9–61·4) in the neoadjuvant chemoradiotherapy plus surgery group and 27·1 months (13·0–41·2) in the surgery alone group (HR 0·73 [95% CI 0·55–0·98]; log-rank p=0·038). Interpretation Long-term follow-up confirms the overall survival benefits for neoadjuvant chemoradiotherapy when added to surgery in patients with resectable oesophageal or oesophagogastric junctional cancer. This improvement is clinically relevant for both squamous cell carcinoma and adenocarcinoma subtypes. Therefore, neoadjuvant chemoradiotherapy according to the CROSS trial followed by surgical resection should be regarded as a standard of care for patients with resectable locally advanced oesophageal or oesophagogastric junctional cancer. Funding Dutch Cancer Foundation (KWF Kankerbestrijding).
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0ISSN: 1470-2045
1EISSN: 1474-5488
2DOI: 10.1016/S1470-2045(15)00040-6
3PMID: 26254683
4CODEN: LANCAO
languageeng
publisherEngland: Elsevier Ltd
subjectAdult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; Cancer therapies ; Carboplatin - administration & dosage ; Cervical cancer ; Chemoradiotherapy ; Chemotherapy ; Disease-Free Survival ; Endoscopy ; Esophageal cancer ; Esophageal Neoplasms - drug therapy ; Esophageal Neoplasms - pathology ; Esophageal Neoplasms - radiotherapy ; Esophageal Neoplasms - surgery ; Esophagogastric Junction - drug effects ; Esophagogastric Junction - pathology ; Esophagogastric Junction - radiation effects ; Esophagogastric Junction - surgery ; Female ; Fluorouracil - administration & dosage ; Hematology, Oncology and Palliative Medicine ; Histology ; Humans ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Mortality ; Neoplasm Staging ; Paclitaxel - administration & dosage ; Radiation therapy ; Squamous cell carcinoma ; Surgery ; Ultrasonic imaging
ispartofThe lancet oncology, 2015, Vol.16 (9), p.1090-1098
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0Shapiro, Joel, Dr
1van Lanschot, J Jan B, Prof
2Hulshof, Maarten C C M, MD
3van Hagen, Pieter, MD
4van Berge Henegouwen, Mark I, MD
5Wijnhoven, Bas P L, MD
6van Laarhoven, Hanneke W M, Prof
7Nieuwenhuijzen, Grard A P, MD
8Hospers, Geke A P, Prof
9Bonenkamp, Johannes J, MD
10Cuesta, Miguel A, Prof
11Blaisse, Reinoud J B, MD
12Busch, Olivier R C, Prof
13ten Kate, Fiebo J W, Prof
14Creemers, Geert-Jan M, MD
15Punt, Cornelis J A, Prof
16Plukker, John Th M, Prof
17Verheul, Henk M W, Prof
18Bilgen, Ernst J Spillenaar, MD
19van Dekken, Herman, MD
20van der Sangen, Maurice J C, MD
21Rozema, Tom, MD
22Biermann, Katharina, MD
23Beukema, Jannet C, MD
24Piet, Anna H M, MD
25van Rij, Caroline M, MD
26Reinders, Janny G, MD
27Tilanus, Hugo W, Prof
28Steyerberg, Ewout W, Prof
29van der Gaast, Ate, MD
30CROSS study group
title
0Neoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months' follow-up. In this Article, we report the long-term results after a minimum follow-up of 5 years. Methods Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2–3N0–1M0, according to the TNM cancer staging system, sixth edition) were randomly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by surgery, or surgery alone. The primary endpoint was overall survival, analysed by intention-to-treat. No adverse event data were collected beyond those noted in the initial report of the trial. This trial is registered with the Netherlands Trial Register, number NTR487, and has been completed. Findings Between March 30, 2004, and Dec 2, 2008, 368 patients from eight participating centres (five academic centres and three large non-academic teaching hospitals) in the Netherlands were enrolled into this study and randomly assigned to the two treatment groups: 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone. Two patients in the neoadjuvant chemoradiotherapy group withdrew consent, so a total of 366 patients were analysed (178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group). Of 171 patients who received any neoadjuvant chemoradiotherapy in this group, 162 (95%) were able to complete the entire neoadjuvant chemoradiotherapy regimen. After a median follow-up for surviving patients of 84·1 months (range 61·1–116·8, IQR 70·7–96·6), median overall survival was 48·6 months (95% CI 32·1–65·1) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months (14·2–33·7) in the surgery alone group (HR 0·68 [95% CI 0·53–0·88]; log-rank p=0·003). Median overall survival for patients with squamous cell carcinomas was 81·6 months (95% CI 47·2–116·0) in the neoadjuvant chemoradiotherapy plus surgery group and 21·1 months (15·4–26·7) in the surgery alone group (HR 0·48 [95% CI 0·28–0·83]; log-rank p=0·008); for patients with adenocarcinomas, it was 43·2 months (24·9–61·4) in the neoadjuvant chemoradiotherapy plus surgery group and 27·1 months (13·0–41·2) in the surgery alone group (HR 0·73 [95% CI 0·55–0·98]; log-rank p=0·038). Interpretation Long-term follow-up confirms the overall survival benefits for neoadjuvant chemoradiotherapy when added to surgery in patients with resectable oesophageal or oesophagogastric junctional cancer. This improvement is clinically relevant for both squamous cell carcinoma and adenocarcinoma subtypes. Therefore, neoadjuvant chemoradiotherapy according to the CROSS trial followed by surgical resection should be regarded as a standard of care for patients with resectable locally advanced oesophageal or oesophagogastric junctional cancer. Funding Dutch Cancer Foundation (KWF Kankerbestrijding).
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2Antineoplastic Combined Chemotherapy Protocols
3Cancer therapies
4Carboplatin - administration & dosage
5Cervical cancer
6Chemoradiotherapy
7Chemotherapy
8Disease-Free Survival
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11Esophageal Neoplasms - drug therapy
12Esophageal Neoplasms - pathology
13Esophageal Neoplasms - radiotherapy
14Esophageal Neoplasms - surgery
15Esophagogastric Junction - drug effects
16Esophagogastric Junction - pathology
17Esophagogastric Junction - radiation effects
18Esophagogastric Junction - surgery
19Female
20Fluorouracil - administration & dosage
21Hematology, Oncology and Palliative Medicine
22Histology
23Humans
24Kaplan-Meier Estimate
25Male
26Middle Aged
27Mortality
28Neoplasm Staging
29Paclitaxel - administration & dosage
30Radiation therapy
31Squamous cell carcinoma
32Surgery
33Ultrasonic imaging
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8Hospers, Geke A P, Prof
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10Cuesta, Miguel A, Prof
11Blaisse, Reinoud J B, MD
12Busch, Olivier R C, Prof
13ten Kate, Fiebo J W, Prof
14Creemers, Geert-Jan M, MD
15Punt, Cornelis J A, Prof
16Plukker, John Th M, Prof
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25van Rij, Caroline M, MD
26Reinders, Janny G, MD
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titleNeoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial
authorShapiro, Joel, Dr ; van Lanschot, J Jan B, Prof ; Hulshof, Maarten C C M, MD ; van Hagen, Pieter, MD ; van Berge Henegouwen, Mark I, MD ; Wijnhoven, Bas P L, MD ; van Laarhoven, Hanneke W M, Prof ; Nieuwenhuijzen, Grard A P, MD ; Hospers, Geke A P, Prof ; Bonenkamp, Johannes J, MD ; Cuesta, Miguel A, Prof ; Blaisse, Reinoud J B, MD ; Busch, Olivier R C, Prof ; ten Kate, Fiebo J W, Prof ; Creemers, Geert-Jan M, MD ; Punt, Cornelis J A, Prof ; Plukker, John Th M, Prof ; Verheul, Henk M W, Prof ; Bilgen, Ernst J Spillenaar, MD ; van Dekken, Herman, MD ; van der Sangen, Maurice J C, MD ; Rozema, Tom, MD ; Biermann, Katharina, MD ; Beukema, Jannet C, MD ; Piet, Anna H M, MD ; van Rij, Caroline M, MD ; Reinders, Janny G, MD ; Tilanus, Hugo W, Prof ; Steyerberg, Ewout W, Prof ; van der Gaast, Ate, MD
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0Adult
1Aged
2Antineoplastic Combined Chemotherapy Protocols
3Cancer therapies
4Carboplatin - administration & dosage
5Cervical cancer
6Chemoradiotherapy
7Chemotherapy
8Disease-Free Survival
9Endoscopy
10Esophageal cancer
11Esophageal Neoplasms - drug therapy
12Esophageal Neoplasms - pathology
13Esophageal Neoplasms - radiotherapy
14Esophageal Neoplasms - surgery
15Esophagogastric Junction - drug effects
16Esophagogastric Junction - pathology
17Esophagogastric Junction - radiation effects
18Esophagogastric Junction - surgery
19Female
20Fluorouracil - administration & dosage
21Hematology, Oncology and Palliative Medicine
22Histology
23Humans
24Kaplan-Meier Estimate
25Male
26Middle Aged
27Mortality
28Neoplasm Staging
29Paclitaxel - administration & dosage
30Radiation therapy
31Squamous cell carcinoma
32Surgery
33Ultrasonic imaging
toplevel
0peer_reviewed
1online_resources
creatorcontrib
0Shapiro, Joel, Dr
1van Lanschot, J Jan B, Prof
2Hulshof, Maarten C C M, MD
3van Hagen, Pieter, MD
4van Berge Henegouwen, Mark I, MD
5Wijnhoven, Bas P L, MD
6van Laarhoven, Hanneke W M, Prof
7Nieuwenhuijzen, Grard A P, MD
8Hospers, Geke A P, Prof
9Bonenkamp, Johannes J, MD
10Cuesta, Miguel A, Prof
11Blaisse, Reinoud J B, MD
12Busch, Olivier R C, Prof
13ten Kate, Fiebo J W, Prof
14Creemers, Geert-Jan M, MD
15Punt, Cornelis J A, Prof
16Plukker, John Th M, Prof
17Verheul, Henk M W, Prof
18Bilgen, Ernst J Spillenaar, MD
19van Dekken, Herman, MD
20van der Sangen, Maurice J C, MD
21Rozema, Tom, MD
22Biermann, Katharina, MD
23Beukema, Jannet C, MD
24Piet, Anna H M, MD
25van Rij, Caroline M, MD
26Reinders, Janny G, MD
27Tilanus, Hugo W, Prof
28Steyerberg, Ewout W, Prof
29van der Gaast, Ate, MD
30CROSS study group
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38MEDLINE - Academic
jtitleThe lancet oncology
delivery
delcategoryRemote Search Resource
fulltextfulltext
addata
au
0Shapiro, Joel, Dr
1van Lanschot, J Jan B, Prof
2Hulshof, Maarten C C M, MD
3van Hagen, Pieter, MD
4van Berge Henegouwen, Mark I, MD
5Wijnhoven, Bas P L, MD
6van Laarhoven, Hanneke W M, Prof
7Nieuwenhuijzen, Grard A P, MD
8Hospers, Geke A P, Prof
9Bonenkamp, Johannes J, MD
10Cuesta, Miguel A, Prof
11Blaisse, Reinoud J B, MD
12Busch, Olivier R C, Prof
13ten Kate, Fiebo J W, Prof
14Creemers, Geert-Jan M, MD
15Punt, Cornelis J A, Prof
16Plukker, John Th M, Prof
17Verheul, Henk M W, Prof
18Bilgen, Ernst J Spillenaar, MD
19van Dekken, Herman, MD
20van der Sangen, Maurice J C, MD
21Rozema, Tom, MD
22Biermann, Katharina, MD
23Beukema, Jannet C, MD
24Piet, Anna H M, MD
25van Rij, Caroline M, MD
26Reinders, Janny G, MD
27Tilanus, Hugo W, Prof
28Steyerberg, Ewout W, Prof
29van der Gaast, Ate, MD
aucorpCROSS study group
formatjournal
genrearticle
ristypeJOUR
atitleNeoadjuvant chemoradiotherapy plus surgery versus surgery alone for oesophageal or junctional cancer (CROSS): long-term results of a randomised controlled trial
jtitleThe lancet oncology
addtitleLancet Oncol
date2015
risdate2015
volume16
issue9
spage1090
epage1098
pages1090-1098
issn1470-2045
eissn1474-5488
codenLANCAO
abstractSummary Background Initial results of the ChemoRadiotherapy for Oesophageal cancer followed by Surgery Study (CROSS) comparing neoadjuvant chemoradiotherapy plus surgery versus surgery alone in patients with squamous cell carcinoma and adenocarcinoma of the oesophagus or oesophagogastric junction showed a significant increase in 5-year overall survival in favour of the neoadjuvant chemoradiotherapy plus surgery group after a median of 45 months' follow-up. In this Article, we report the long-term results after a minimum follow-up of 5 years. Methods Patients with clinically resectable, locally advanced cancer of the oesophagus or oesophagogastric junction (clinical stage T1N1M0 or T2–3N0–1M0, according to the TNM cancer staging system, sixth edition) were randomly assigned in a 1:1 ratio with permuted blocks of four or six to receive either weekly administration of five cycles of neoadjuvant chemoradiotherapy (intravenous carboplatin [AUC 2 mg/mL per min] and intravenous paclitaxel [50 mg/m2 of body-surface area] for 23 days) with concurrent radiotherapy (41·4 Gy, given in 23 fractions of 1·8 Gy on 5 days per week) followed by surgery, or surgery alone. The primary endpoint was overall survival, analysed by intention-to-treat. No adverse event data were collected beyond those noted in the initial report of the trial. This trial is registered with the Netherlands Trial Register, number NTR487, and has been completed. Findings Between March 30, 2004, and Dec 2, 2008, 368 patients from eight participating centres (five academic centres and three large non-academic teaching hospitals) in the Netherlands were enrolled into this study and randomly assigned to the two treatment groups: 180 to surgery plus neoadjuvant chemoradiotherapy and 188 to surgery alone. Two patients in the neoadjuvant chemoradiotherapy group withdrew consent, so a total of 366 patients were analysed (178 in the neoadjuvant chemoradiotherapy plus surgery group and 188 in the surgery alone group). Of 171 patients who received any neoadjuvant chemoradiotherapy in this group, 162 (95%) were able to complete the entire neoadjuvant chemoradiotherapy regimen. After a median follow-up for surviving patients of 84·1 months (range 61·1–116·8, IQR 70·7–96·6), median overall survival was 48·6 months (95% CI 32·1–65·1) in the neoadjuvant chemoradiotherapy plus surgery group and 24·0 months (14·2–33·7) in the surgery alone group (HR 0·68 [95% CI 0·53–0·88]; log-rank p=0·003). Median overall survival for patients with squamous cell carcinomas was 81·6 months (95% CI 47·2–116·0) in the neoadjuvant chemoradiotherapy plus surgery group and 21·1 months (15·4–26·7) in the surgery alone group (HR 0·48 [95% CI 0·28–0·83]; log-rank p=0·008); for patients with adenocarcinomas, it was 43·2 months (24·9–61·4) in the neoadjuvant chemoradiotherapy plus surgery group and 27·1 months (13·0–41·2) in the surgery alone group (HR 0·73 [95% CI 0·55–0·98]; log-rank p=0·038). Interpretation Long-term follow-up confirms the overall survival benefits for neoadjuvant chemoradiotherapy when added to surgery in patients with resectable oesophageal or oesophagogastric junctional cancer. This improvement is clinically relevant for both squamous cell carcinoma and adenocarcinoma subtypes. Therefore, neoadjuvant chemoradiotherapy according to the CROSS trial followed by surgical resection should be regarded as a standard of care for patients with resectable locally advanced oesophageal or oesophagogastric junctional cancer. Funding Dutch Cancer Foundation (KWF Kankerbestrijding).
copEngland
pubElsevier Ltd
pmid26254683
doi10.1016/S1470-2045(15)00040-6