Low-Dose Radiation Is Sufficient for the Noninvolved Extended-Field Treatment in Favorable Early-Stage Hodgkin’s Disease: Long-Term Results of a Randomized Trial of Radiotherapy Alone

To show that radiotherapy (RT) dose to the noninvolved extended field (EF) can be reduced without loss of efficacy in patients with early-stage Hodgkin's disease (HD). During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal...

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Veröffentlicht in:Journal of clinical oncology 2001-06, Vol.19 (11), p.2905-2914
Hauptverfasser: DÜHMKE, Eckhart, FRANKLIN, Jeremy, LATHAN, Bernd, RÜFFER, Ulrich, SIEBER, Markus, WOLF, Jürgen, ENGERT, Andreas, GEORGII, Axel, STAAR, Susanne, HERRMANN, Richard, BEYKIRCH, Maria, KIRCHNER, Hartmut, PFREUNDSCHUH, Michael, EMMINGER, Adelheid, GREIL, Richard, FRITSCH, Esther, KOCH, Peter, DROCHTERT, Angelika, BROSTEANU, Oana, HASENCLEVER, Dirk, LOEFFLER, Markus, DIEHL, Volker, SEHLEN, Susanne, WILLICH, Norman, RÜHL, Ursula, MÜLLER, Rolf-Peter, LUKAS, Peter, ATZINGER, Anton, PAULUS, Ursula
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container_end_page 2914
container_issue 11
container_start_page 2905
container_title Journal of clinical oncology
container_volume 19
creator DÜHMKE, Eckhart
FRANKLIN, Jeremy
LATHAN, Bernd
RÜFFER, Ulrich
SIEBER, Markus
WOLF, Jürgen
ENGERT, Andreas
GEORGII, Axel
STAAR, Susanne
HERRMANN, Richard
BEYKIRCH, Maria
KIRCHNER, Hartmut
PFREUNDSCHUH, Michael
EMMINGER, Adelheid
GREIL, Richard
FRITSCH, Esther
KOCH, Peter
DROCHTERT, Angelika
BROSTEANU, Oana
HASENCLEVER, Dirk
LOEFFLER, Markus
DIEHL, Volker
SEHLEN, Susanne
WILLICH, Norman
RÜHL, Ursula
MÜLLER, Rolf-Peter
LUKAS, Peter
ATZINGER, Anton
PAULUS, Ursula
description To show that radiotherapy (RT) dose to the noninvolved extended field (EF) can be reduced without loss of efficacy in patients with early-stage Hodgkin's disease (HD). During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal mass, extranodal lesions, massive splenic disease, elevated erythrocyte sedimentation rate, or three or more involved areas) were recruited from various centers. All patients received 40 Gy total fractionated dose to the involved field areas but were randomly assigned to receive either 40 Gy (arm A) or 30 Gy (arm B) total fractionated dose for the clinically noninvolved EF. No chemotherapy was given. RT films were prospectively reviewed for protocol violations and recurrences retrospectively related to the applied RT. Of 382 recruited patients, 376 were eligible for randomized comparison, 190 in arm A and 186 in arm B. Complete remission was attained in 98% of patients in each arm. With a median follow-up of 86 months, 7-year relapse-free survival (RFS) rates were 78% (arm A) and 83% (arm B) (P =.093). The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P =.16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. Relapse patterns suggest that systemic therapy can reduce the 20% long-term relapse rate.
doi_str_mv 10.1200/jco.2001.19.11.2905
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The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P =.16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. 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During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal mass, extranodal lesions, massive splenic disease, elevated erythrocyte sedimentation rate, or three or more involved areas) were recruited from various centers. All patients received 40 Gy total fractionated dose to the involved field areas but were randomly assigned to receive either 40 Gy (arm A) or 30 Gy (arm B) total fractionated dose for the clinically noninvolved EF. No chemotherapy was given. RT films were prospectively reviewed for protocol violations and recurrences retrospectively related to the applied RT. Of 382 recruited patients, 376 were eligible for randomized comparison, 190 in arm A and 186 in arm B. Complete remission was attained in 98% of patients in each arm. With a median follow-up of 86 months, 7-year relapse-free survival (RFS) rates were 78% (arm A) and 83% (arm B) (P =.093). The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P =.16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. Relapse patterns suggest that systemic therapy can reduce the 20% long-term relapse rate.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Biological and medical sciences</subject><subject>Dose Fractionation</subject><subject>Female</subject><subject>Hemopathies</subject><subject>Hodgkin Disease - pathology</subject><subject>Hodgkin Disease - radiotherapy</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Patient Compliance</subject><subject>Prognosis</subject><subject>Radiotherapy - methods</subject><subject>Radiotherapy Dosage</subject><subject>Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. 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During 1988 to 1994, pathologically staged patients with stage I or II disease who were without risk factors (large mediastinal mass, extranodal lesions, massive splenic disease, elevated erythrocyte sedimentation rate, or three or more involved areas) were recruited from various centers. All patients received 40 Gy total fractionated dose to the involved field areas but were randomly assigned to receive either 40 Gy (arm A) or 30 Gy (arm B) total fractionated dose for the clinically noninvolved EF. No chemotherapy was given. RT films were prospectively reviewed for protocol violations and recurrences retrospectively related to the applied RT. Of 382 recruited patients, 376 were eligible for randomized comparison, 190 in arm A and 186 in arm B. Complete remission was attained in 98% of patients in each arm. With a median follow-up of 86 months, 7-year relapse-free survival (RFS) rates were 78% (arm A) and 83% (arm B) (P =.093). The upper 95% confidence limit for the possible inferiority of arm B in RFS was 4%. Corresponding overall survival rates were 91% (arm A) and 96% (arm B) (P =.16). The most common causes of death (n = 27) were cardiorespiratory disease/pulmonary embolisms (seven), second malignancy (six), and HD (five). Protocol violation was associated with significantly poorer RFS. Nonirradiated nodes were involved in 42 of 52 reviewed relapses, infield areas in 18, marginal areas in 17, and extranodal sites in 16. EF-RT alone attains good survival rates in favorable early-stage HD. The 30-Gy dose is adequate for clinically noninvolved areas. Protocol violation worsens the subsequent prognosis. Relapse patterns suggest that systemic therapy can reduce the 20% long-term relapse rate.</abstract><cop>Baltimore, MD</cop><pub>American Society of Clinical Oncology</pub><pmid>11387364</pmid><doi>10.1200/jco.2001.19.11.2905</doi><tpages>10</tpages></addata></record>
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identifier ISSN: 0732-183X
ispartof Journal of clinical oncology, 2001-06, Vol.19 (11), p.2905-2914
issn 0732-183X
1527-7755
language eng
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source MEDLINE; Journals@Ovid Complete
subjects Adolescent
Adult
Aged
Biological and medical sciences
Dose Fractionation
Female
Hemopathies
Hodgkin Disease - pathology
Hodgkin Disease - radiotherapy
Humans
Male
Medical sciences
Middle Aged
Patient Compliance
Prognosis
Radiotherapy - methods
Radiotherapy Dosage
Radiotherapy. Instrumental treatment. Physiotherapy. Reeducation. Rehabilitation, orthophony, crenotherapy. Diet therapy and various other treatments (general aspects)
Survival Analysis
Treatment Outcome
title Low-Dose Radiation Is Sufficient for the Noninvolved Extended-Field Treatment in Favorable Early-Stage Hodgkin’s Disease: Long-Term Results of a Randomized Trial of Radiotherapy Alone
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