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EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment

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EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. / Whelan, J S; Bielack, S S; Marina, N; Smeland, S; Jovic, G; Hook, J M; Krailo, M; Anninga, J; Butterfass-Bahloul, T; Böhling, T; Calaminus, G; Capra, M; Deffenbaugh, C; Dhooge, C; Eriksson, M; Flanagan, A M; Gelderblom, H; Goorin, A; Gorlick, R; Gosheger, G; Grimer, R J; Hall, K S; Helmke, K; Hogendoorn, P C W; Jundt, G; Kager, L; Kuehne, T; Lau, C C; Letson, G D; Meyer, J; Meyers, P A; Morris, C; Mottl, H; Nadel, H; Nagarajan, R; Randall, R L; Schomberg, P; Schwarz, R; Teot, L A; Sydes, M R; Bernstein, M; EURAMOS collaborators.

In: ANN ONCOL, Vol. 26, No. 2, 02.2015, p. 407-14.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Whelan, JS, Bielack, SS, Marina, N, Smeland, S, Jovic, G, Hook, JM, Krailo, M, Anninga, J, Butterfass-Bahloul, T, Böhling, T, Calaminus, G, Capra, M, Deffenbaugh, C, Dhooge, C, Eriksson, M, Flanagan, AM, Gelderblom, H, Goorin, A, Gorlick, R, Gosheger, G, Grimer, RJ, Hall, KS, Helmke, K, Hogendoorn, PCW, Jundt, G, Kager, L, Kuehne, T, Lau, CC, Letson, GD, Meyer, J, Meyers, PA, Morris, C, Mottl, H, Nadel, H, Nagarajan, R, Randall, RL, Schomberg, P, Schwarz, R, Teot, LA, Sydes, MR, Bernstein, M & EURAMOS collaborators 2015, 'EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment', ANN ONCOL, vol. 26, no. 2, pp. 407-14. https://doi.org/10.1093/annonc/mdu526

APA

Whelan, J. S., Bielack, S. S., Marina, N., Smeland, S., Jovic, G., Hook, J. M., Krailo, M., Anninga, J., Butterfass-Bahloul, T., Böhling, T., Calaminus, G., Capra, M., Deffenbaugh, C., Dhooge, C., Eriksson, M., Flanagan, A. M., Gelderblom, H., Goorin, A., Gorlick, R., ... EURAMOS collaborators (2015). EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. ANN ONCOL, 26(2), 407-14. https://doi.org/10.1093/annonc/mdu526

Vancouver

Whelan JS, Bielack SS, Marina N, Smeland S, Jovic G, Hook JM et al. EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment. ANN ONCOL. 2015 Feb;26(2):407-14. https://doi.org/10.1093/annonc/mdu526

Bibtex

@article{39ee6e5385fd455d8307a04d26eb5b15,
title = "EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment",
abstract = "BACKGROUND: Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response.PATIENTS AND METHODS: Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with <10% viable tumour were allocated to MAP or MAP followed by pegylated interferon. Longitudinal evaluation of quality of life was undertaken.RESULTS: Recruitment was completed to the largest osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen.CONCLUSIONS: New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327.",
author = "Whelan, {J S} and Bielack, {S S} and N Marina and S Smeland and G Jovic and Hook, {J M} and M Krailo and J Anninga and T Butterfass-Bahloul and T B{\"o}hling and G Calaminus and M Capra and C Deffenbaugh and C Dhooge and M Eriksson and Flanagan, {A M} and H Gelderblom and A Goorin and R Gorlick and G Gosheger and Grimer, {R J} and Hall, {K S} and K Helmke and Hogendoorn, {P C W} and G Jundt and L Kager and T Kuehne and Lau, {C C} and Letson, {G D} and J Meyer and Meyers, {P A} and C Morris and H Mottl and H Nadel and R Nagarajan and Randall, {R L} and P Schomberg and R Schwarz and Teot, {L A} and Sydes, {M R} and M Bernstein and {EURAMOS collaborators}",
note = "{\textcopyright} The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.",
year = "2015",
month = feb,
doi = "10.1093/annonc/mdu526",
language = "English",
volume = "26",
pages = "407--14",
journal = "ANN ONCOL",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "2",

}

RIS

TY - JOUR

T1 - EURAMOS-1, an international randomised study for osteosarcoma: results from pre-randomisation treatment

AU - Whelan, J S

AU - Bielack, S S

AU - Marina, N

AU - Smeland, S

AU - Jovic, G

AU - Hook, J M

AU - Krailo, M

AU - Anninga, J

AU - Butterfass-Bahloul, T

AU - Böhling, T

AU - Calaminus, G

AU - Capra, M

AU - Deffenbaugh, C

AU - Dhooge, C

AU - Eriksson, M

AU - Flanagan, A M

AU - Gelderblom, H

AU - Goorin, A

AU - Gorlick, R

AU - Gosheger, G

AU - Grimer, R J

AU - Hall, K S

AU - Helmke, K

AU - Hogendoorn, P C W

AU - Jundt, G

AU - Kager, L

AU - Kuehne, T

AU - Lau, C C

AU - Letson, G D

AU - Meyer, J

AU - Meyers, P A

AU - Morris, C

AU - Mottl, H

AU - Nadel, H

AU - Nagarajan, R

AU - Randall, R L

AU - Schomberg, P

AU - Schwarz, R

AU - Teot, L A

AU - Sydes, M R

AU - Bernstein, M

AU - EURAMOS collaborators

N1 - © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

PY - 2015/2

Y1 - 2015/2

N2 - BACKGROUND: Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response.PATIENTS AND METHODS: Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with <10% viable tumour were allocated to MAP or MAP followed by pegylated interferon. Longitudinal evaluation of quality of life was undertaken.RESULTS: Recruitment was completed to the largest osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen.CONCLUSIONS: New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327.

AB - BACKGROUND: Four international study groups undertook a large study in resectable osteosarcoma, which included two randomised controlled trials, to determine the effect on survival of changing post-operative chemotherapy based on histological response.PATIENTS AND METHODS: Patients with resectable osteosarcoma aged ≤40 years were treated with the MAP regimen, comprising pre-operatively of two 5-week cycles of cisplatin 120 mg/m(2), doxorubicin 75 mg/m(2), methotrexate 12 g/m(2) × 2 (MAP) and post-operatively two further cycles of MAP and two cycles of just MA. Patients were randomised after surgery. Those with ≥10% viable tumour in the resected specimen received MAP or MAP with ifosfamide and etoposide. Those with <10% viable tumour were allocated to MAP or MAP followed by pegylated interferon. Longitudinal evaluation of quality of life was undertaken.RESULTS: Recruitment was completed to the largest osteosarcoma study to date in 75 months. Commencing March 2005, 2260 patients were registered from 326 centres across 17 countries. About 1334 of 2260 registered patients (59%) were randomised. Pre-operative chemotherapy was completed according to protocol in 94%. Grade 3-4 neutropenia affected 83% of cycles and 59% were complicated by infection. There were three (0.13%) deaths related to pre-operative chemotherapy. At definitive surgery, 50% of patients had at least 90% necrosis in the resected specimen.CONCLUSIONS: New models of collaboration are required to successfully conduct trials to improve outcomes of patients with rare cancers; EURAMOS-1 demonstrates achievability. Considerable regulatory, financial and operational challenges must be overcome to develop similar studies in the future. The trial is registered as NCT00134030 and ISRCTN 67613327.

U2 - 10.1093/annonc/mdu526

DO - 10.1093/annonc/mdu526

M3 - SCORING: Journal article

C2 - 25421877

VL - 26

SP - 407

EP - 414

JO - ANN ONCOL

JF - ANN ONCOL

SN - 0923-7534

IS - 2

ER -