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Hodgkin's Lymphoma in Adolescents Treated With Adult Protocols: A Report From the German Hodgkin Study Group

Eichenauer, Dennis A. ; Bredenfeld, Henning ; Haverkamp, Heinz ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2009

In: Journal of Clinical Oncology Vol. 27, No. 36 ( 2009-12-20), p. 6079-6085

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 27, No. 36 ( 2009-12-20), p. 6079-6085

Abstract: The standard of care for adolescent patients with Hodgkin's lymphoma (HL) is undefined, particularly the choice between pediatric and adult protocols. Thus, we compared risk factors and outcome of adolescents and young adults treated within study protocols of the German Hodgkin Study Group (GHSG). Patients and Methods Three thousand seven hundred eighty-five patients treated within the GHSG studies HD4 to HD9 were analyzed; 557 patients were adolescents age 15 to 20 years, and 3,228 patients were young adults age 21 to 45 years. Results Large mediastinal mass and involvement of three or more lymph node areas were more frequent in adolescents (P 〈 .001). The incidence of other risk factors did not differ significantly between age groups. With a median observation time of 81 months for freedom from treatment failure (FFTF) and 85 months for overall survival (OS), log-rank test showed no significant differences between age groups regarding FFTF (P = .305) and a superior OS (P = .008) for adolescents. Six-year estimates for FFTF and OS were 80% and 94%, respectively, for adolescents and 80% and 91%, respectively, for young adults. After adjustment for other predictive factors, Cox regression analysis revealed age as a significant predictor for OS (P = .004), with a higher mortality risk for young adults. Secondary malignancies were more common in young adults (P = .037). Conclusion Outcome of adolescent and young adult patients treated within GHSG study protocols is comparable. These data suggest that adult treatment protocols exhibit a safe and effective treatment option for adolescent patients with HL. However, longer follow-up, including assessment of late toxicity, is necessary for final conclusions.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2008.20.2655

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XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2009

detail.hit.zdb_id: 2005181-5

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Combined Modality Treatment with Intensified Chemotherapy and Dose-Reduced Involved Field Radiotherapy in Patients with Early Unfavourable Hodgkin Lymphoma (HL): Final Analysis of the German Hodgkin Study Group (GHSG) HD11 Trial.

Borchmann, Peter ; Diehl, Volker ; Goergen, Helen ; [et al.]

American Society of Hematology ; 2009

In: Blood Vol. 114, No. 22 ( 2009-11-20), p. 717-717

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In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 717-717

Abstract: Abstract 717 Purpose: Combined modality treatment consisting of 4 cycles of chemotherapy (CT) followed by involved field radiotherapy (IF-RT) is the standard treatment for early unfavourable HL. In our prior trial for this group of patients (HD8), overall survival (OS) and freedom from treatment failure (FFTF) at 5 years were 91% and 83%, respectively. The HD11 trial thus addressed two major questions: (1) improving outcome by intensifying CT (4xABVD vs. 4xBEACOPPbaseline; Bbas) and (2) defining the best radiation dose (30Gy vs. 20Gy IF-RT). Patients and methods: Between May 1998 and January 2003, 1395 eligible patients aged 16–75 years with untreated early unfavourable stage HL (CS I, IIA with at least one of the risk factors large mediastinal mass (a), extranodal disease (b), elevated ESR (c) or ≥ 3 nodal areas (d); IIB with risk factors c and/or d) were randomized into one of the following 4 treatment arms: 4xABVD + 30Gy (A), 4xABVD + 20Gy (B), 4x Bbas + 30Gy (C) or 4x Bbas + 20Gy (D). Since there are strong indications for an interaction between CT- and RT-doses, a comparison of pooled treatment arms (A+B vs. C+D for comparison of 4×ABVD vs. 4× Bbas and A+C vs. B+D for comparison of 30Gy IF-RT vs. 20Gy IF-RT) would be misleading. Therefore all treatment arms were analysed separately. Results: Patient characteristics were well balanced between the 4 arms (median age 33 years, 49% male, 6% stage I, 29% B-symptoms). CT- and RT-related acute toxicity occurred significantly more often in the arms with the more intensive therapy (CT: 74.1% vs. 51.8%; RT: 12.3% vs. 5.5%). The complete remission rate 3 months after end of therapy was 94.1% for the whole group and did not differ significantly between the 4 arms. The 5-year estimate of FFTF (primary endpoint) is 85.0% (OS 94.5%, PFS 86.0%). Bbas is more effective than ABVD if followed by 20Gy IF-RT (5y-FFTF difference 5.7%, 95%-CI [0.1%; 11.3%]). This effect does not exist in combination with 30Gy IF-RT (5y-FFTF difference 1.6% [-3.6%; 6.9%] ). Similar results are observed for the RT-question: After 4 cycles of Bbas, 20Gy is not inferior to 30Gy (5y-FFTF difference -0.1%, 95%-CI [-5.1%; 4.9%]), whereas after 4xABVD, a relevant inferiority of 20Gy cannot be excluded (-4.0% [-9.5%; 1.4%] ). Conclusion: A reduction of RT dose from 30Gy to 20Gy IF-RT seems to be justified only in combination with Bbas, but not with a less effective chemotherapy such as 4xABVD. Patients will benefit from an intensified CT such as Bbas only in combination with 20Gy IF-RT but not with 30Gy IF-RT. Disclosures: No relevant conflicts of interest to declare.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V114.22.717.717

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Language: English

Publisher: American Society of Hematology

Publication Date: 2009

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Reduced Treatment Intensity in Patients with Early-Stage Hodgkin's Lymphoma

Engert, Andreas ; Plütschow, Annette ; Eich, Hans Theodor ; [et al.]

Massachusetts Medical Society ; 2010

In: New England Journal of Medicine Vol. 363, No. 7 ( 2010-08-12), p. 640-652

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In: New England Journal of Medicine, Massachusetts Medical Society, Vol. 363, No. 7 ( 2010-08-12), p. 640-652

Type of Medium: Online Resource

ISSN: 0028-4793 , 1533-4406

URL: Article

DOI: 10.1056/NEJMoa1000067

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Language: English

Publisher: Massachusetts Medical Society

Publication Date: 2010

detail.hit.zdb_id: 1468837-2

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Two Cycles of Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine Plus Extended-Field Radiotherapy Is Superior to Radiotherapy Alone in Early Favorable Hodgkin's Lymphoma: Final Results of the GHSG HD7 Trial

Engert, Andreas ; Franklin, Jeremy ; Eich, Hans Theodor ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2007

In: Journal of Clinical Oncology Vol. 25, No. 23 ( 2007-08-10), p. 3495-3502

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 25, No. 23 ( 2007-08-10), p. 3495-3502

Abstract: To investigate whether combined-modality treatment (CMT) with two cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) followed by extended-field radiotherapy (EF-RT) is superior to EF-RT alone in patients with early favorable Hodgkin's lymphoma (HL). Patients and Methods Between 1993 and 1998, 650 patients with newly diagnosed, histology-proven HL in clinical stages IA to IIB without risk factors were enrolled onto this multicenter study and randomly assigned to receive 30 Gy EF-RT plus 10 Gy to the involved field (arm A) or two cycles of ABVD followed by the same radiotherapy (arm B). Results At a median observation time of 87 months, there was no difference between treatment arms in terms of complete response rate (arm A, 95%; arm B, 94%) and overall survival (at 7 years: arm A, 92%; arm B, 94%; P = .43). However, freedom from treatment failure was significantly different, with 7-year rates of 67% in arm A (95% CI, 61% to 73%) and 88% in arm B (95% CI, 84% to 92%; P ≤ .0001). This was due mainly to significantly more relapses after EF-RT only (arm A, 22%; arm B, 3%). No patient treated with CMT experienced relapse before year 3. Relapses were treated mainly with bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, or with the combination cyclophosphamide, vincristine, procarbazine, and prednisone/ABVD; treatment of relapse was significantly more successful in arm A than in arm B (P = .017). In total, there were 39 second malignancies, with 21 in arm A and 18 in arm B, respectively. The incidence was approximately 0.8% per year during years 2 to 9 and was highest in older patients (P 〈 .0001) and those with “B” symptoms (P = .012). Conclusion CMT consisting of two cycles of ABVD plus EF-RT is more effective than EF-RT alone.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2006.07.0482

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XA 52760

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Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2007

detail.hit.zdb_id: 2005181-5

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Involved-Field Radiotherapy Is Equally Effective and Less Toxic Compared With Extended-Field Radiotherapy After Four Cycles of Chemotherapy in Patients With Early-Stage Unfavorable Hodgkin’s Lymphoma: Results of the HD8 Trial of the German Hodgkin’s Lymphoma Study Group

Engert, Andreas ; Schiller, Petra ; Josting, Andreas ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2003

In: Journal of Clinical Oncology Vol. 21, No. 19 ( 2003-10-01), p. 3601-3608

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 21, No. 19 ( 2003-10-01), p. 3601-3608

Abstract: Purpose: To investigate whether radiotherapy can be reduced without loss of efficacy from extended field (EF) to involved field (IF) after four cycles of chemotherapy. Patients and Methods: Between 1993 and 1998, patients with newly diagnosed early-stage unfavorable HD were enrolled onto this multicenter study. Patients were randomly assigned to receive cyclophosphamide, vincristine, procarbazine, and prednisone (COPP) + doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) for two cycles followed by radiotherapy of 30 Gy EF + 10 Gy to bulky disease (arm A) or 30 Gy IF + 10 Gy to bulky disease (arm B). Results: Of 1,204 patients randomly assigned to treatment, 1,064 patients were informative and eligible for the arm comparison (532 patients in arm A; 532 patients in arm B). The median observation time was 54 months. Five years after random assignment, the overall survival (OS ran ) for all eligible patients was 91% and freedom from treatment failure (FFTF ran ) was 83%. Survival rates at 5 years after start of radiotherapy revealed no differences for arms A and B, respectively, in terms of FFTF (85.8% and 84.2%) and OS at 5 years (90.8% and 92.4%). There also were no differences between arms A and B, respectively, in terms of complete remission (98.5% and 97.2%), progressive disease (0.8% and 1.9%), relapse (6.4% and 7.7%), death (8.1% and 6.4%), and secondary neoplasia (4.5% and 2.8%). In contrast, acute side effects including leukopenia, thrombocytopenia, nausea, gastrointestinal toxicity, and pharyngeal toxicity were more frequent in the EF arm. Conclusion: Radiotherapy volume size reduction from EF to IF after COPP + ABVD chemotherapy for two cycles produces similar results and less toxicity in patients with early-stage unfavorable HD.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2003.03.023

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XA 52760

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XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2003

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Eight Cycles of Escalated-Dose BEACOPP Compared With Four Cycles of Escalated-Dose BEACOPP Followed by Four Cycles of Baseline-Dose BEACOPP With or Without Radiotherapy in Patients With Advanced-Stage Hodgkin's Lymphoma: Final Analysis of the HD12 Trial of the German Hodgkin Study Group

Borchmann, Peter ; Haverkamp, Heinz ; Diehl, Volker ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2011

In: Journal of Clinical Oncology Vol. 29, No. 32 ( 2011-11-10), p. 4234-4242

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 29, No. 32 ( 2011-11-10), p. 4234-4242

Abstract: Eight cycles of BEACOPP escalated (escalated dose of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) followed by radiotherapy (RT) to initial bulk or residual tumor mass is the German Hodgkin Study Group standard of care for advanced-stage Hodgkin's lymphoma (HL). However, treatment-related toxicity is a concern, and the role of RT in this setting is unclear. The HD12 study thus aimed to reduce toxicity while maintaining efficacy. Patients and Methods In this prospectively randomized multicenter trial, eight cycles of BEACOPP escalated was compared with four cycles of BEACOPP escalated followed by four cycles of the baseline dose of BEACOPP (BEACOPP baseline ; 4 + 4), and RT with no RT in the case of initial bulk or residual disease. The study was designed to exclude a difference in 5-year freedom from treatment failure (FFTF) rate of 6%. Results Between January 1999 and January 2003, 1,670 patients age 16 to 65 years were enrolled onto the HD12 study. At 5 years, FFTF was 86.4% in the BEACOPP escalated arm and 84.8% in the 4 + 4 arm (difference, −1.6%; 95% CI, −5.2% to 1.9%), and overall survival was 92% versus 90.3% (difference, −1.7%; 95% CI, −4.6% to 1.1%). Deaths related to acute toxicity of chemotherapy were observed in 2.9% of patients (BEACOPP escalated , n = 19; 4 + 4, n = 27). FFTF was inferior without RT (90.4% v 87%; difference, −3.4%; 95% CI, −6.6% to −0.1%), particularly in patients who had residual disease after chemotherapy (difference, −5.8%; 95% CI, −10.7% to −1.0%), but not in patients with bulk in complete response after chemotherapy (difference, −1.1%; 95% CI, −6.2% to 4%). Conclusion The reduction of BEACOPP to the 4 + 4 regimen did not substantially reduce severe toxicity but might decrease efficacy. Our results do not support the omission of consolidation RT for patients with residual disease. Alternative strategies for improving the risk-to-benefit ratio for patients with advanced HL are needed.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2010.33.9549

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XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2011

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Two Cycles of ABVD Followed by Involved Field Radiotherapy with 20 Gray (Gy) Is the New Standard of Care in the Treatment of Patients with Early-Stage Hodgkin Lymphoma: Final Analysis of the Randomized German Hodgkin Study Group (GHSG) HD10. Study Supported by the Deutsche Krebshilfe and in Part by the Competence Network Malignant Lymphoma.

Engert, Andreas ; Diehl, Volker ; Pluetschow, Annette ; [et al.]

American Society of Hematology ; 2009

In: Blood Vol. 114, No. 22 ( 2009-11-20), p. 716-716

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In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 716-716

Abstract: Abstract 716 Background: There has been an ongoing debate on the best treatment for patients with early favourable Hodgkin lymphoma (HL). Open questions include the choice between combined modality treatment or chemotherapy only, the number of chemotherapy cycles needed and the optimal radiation dose. The GHSG thus conducted a randomized study for patients with early-stage favourable Hodgkin lymphoma (HD10) in which these questions were addressed. Methods: HD10 was an international prospectively randomized multicenter trial comparing 2 and 4 cycles of ABVD as well as 20Gy or 30Gy involved field radiotherapy (IFRT) in a 2 × 2 statistical design. Between 5/1998 and 1/2003, a total of 1370 patients from 329 centers were randomized into four arms: 4 × ABVD + 30Gy; 4 × ABVD + 20Gy; 2 × ABVD + 30Gy; 2 × ABVD + 20Gy. All patients had their initial histology reviewed by a lymphoma expert panel. Documentation was complete in more than 99,1% of cases for this final analysis. Results: Patients were equally balanced for age, gender, stage, histology, performance status and risk factors between arms. There were significant differences in major toxicity (WHO grade III/IV) between 4 × ABVD and 2 × ABVD in the overall number of events (52% vs 33%) including leukopenia (24% vs 15%) and hair loss (28% vs 15%). In terms of radiation dose, there also was a difference in toxicity between 30Gy and 20Gy IFRT (all events: 8.7% vs 2.9%), dysphagia (3% vs 2%), mucositis (3.4% vs 0.7%). Complete remission was achieved in 97% of patients treated with 4 × ABVD, 97% with 2 × ABVD, 99% after 30Gy and 97% after 20Gy. With a median follow-up of 79–91 months, there was no significant difference between 4 × ABVD and 2 × ABVD in terms of overall survival at 5 years (OS: 4 × ABVD 97.1%; 2 × ABVD: 96.6%), freedom from treatment failure (FFTF: 93.0% vs 91.1%) and progression free survival (PFS: 93.5% vs 91.2%). For the radiotherapy question, there were also no significant differences between patients receiving 30Gy IFRT and those with 20Gy IFRT in terms of OS (97.6% vs 97.5%), FFTF (93.4% vs 92.9%) and PFS (93.7% vs 93.2%), respectively. Importantly, there was also no significant difference in terms of OS, FFTF and PFS when all four arms were compared. Conclusion: Two cycles of ABVD followed by 20Gy IFRT is the new GHSG standard of care for Hodgkin patients in early favourable stages. Disclosures: No relevant conflicts of interest to declare.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V114.22.716.716

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XA 33000

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XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2009

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Hodgkin Lymphoma in Adolescents Treated with Adult Protocols: An Analysis From the German Hodgkin Study Group (GHSG).

Eichenauer, Dennis A. ; Bredenfeld, Henning ; Franklin, Jeremy ; [et al.]

American Society of Hematology ; 2009

In: Blood Vol. 114, No. 22 ( 2009-11-20), p. 719-719

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In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 719-719

Abstract: Abstract 719 Introduction: The standard of care for adolescent Hodgkin lymphoma (HL) patients is undefined, particularly the choice between adult and pediatric protocols. We thus analyzed and compared risk factors, outcome and incidence of secondary malignancies in adolescents and young adults treated within study protocols of the German Hodgkin Study Group (GHSG) to evaluate whether adolescents represent a distinct patient group. Patients and Methods: 3785 patients of all stages treated within the second (HD4-HD6, 1988-1993) and third (HD7-HD9, 1993-1998) trial generation of the GHSG were retrospectively analyzed. 557 patients were adolescents aged 15 to 20 and 3228 patients were young adults aged 21 to 45. Treatment consisted of chemo- and/or radiotherapy. Results: The risk factors large mediastinal mass (more than 1/3 of the maximum intrathoracic diameter) and involvement of three or more lymph node areas were more common in adolescents (30.2% vs. 20.9% and 67.7% vs. 58.7%, respectively, p 〈 .001). The incidence of other risk factors did not differ significantly between age groups. With a median follow-up of 81 months for freedom from treatment failure (FFTF) and 85 months for overall survival (OS), FFTF rates in both groups were comparable (p=.305) while adolescents had a superior OS (p=.008). 6-year FFTF estimates were 80.2% and 79.7%, 6-year OS estimates were 93.6% and 90.9% in adolescents and young adults, respectively. Young adults had a higher risk to develop secondary malignancies. Secondary malignancy rates were 1.6% (9 of 557) in adolescents and 3.1% (101 of 3228) in young adults with secondary hematological malignancies (AML/MDS, NHL) representing the majority of cases in both groups (6/9 in adolescents and 55/101 in young adults). Since adolescents differ from young adults in terms of cancer risk in the general population, standardized incidence ratio (SIR) and absolute excess risk (AER) per 100.000 person-years were calculated. The SIR was higher in adolescents (5.56 vs. 4.58) while the AER was higher in young adults (394 vs. 194). However, differences between age groups were not significant for both. Conclusions: There are only slight differences between adolescents and young adults regarding risk factors, outcome and incidence of secondary malignancies. Therefore, treatment with adult protocols can be considered effective and safe in adolescent HL patients. Disclosures: No relevant conflicts of interest to declare.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V114.22.719.719

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XA 33000

RVK:

XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2009

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

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Intensified Chemotherapy and Dose-Reduced Involved-Field Radiotherapy in Patients With Early Unfavorable Hodgkin's Lymphoma: Final Analysis of the German Hodgkin Study Group HD11 Trial

Eich, Hans Theodor ; Diehl, Volker ; Görgen, Helen ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2010

In: Journal of Clinical Oncology Vol. 28, No. 27 ( 2010-09-20), p. 4199-4206

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 28, No. 27 ( 2010-09-20), p. 4199-4206

Abstract: Combined-modality treatment consisting of four to six cycles of chemotherapy followed by involved-field radiotherapy (IFRT) is the standard of care for patients with early unfavorable Hodgkin's lymphoma (HL). It is unclear whether treatment results can be improved with more intensive chemotherapy and which radiation dose needs to be applied. Patients and Methods Patients age 16 to 75 years with newly diagnosed early unfavorable HL were randomly assigned in a 2 × 2 factorial design to one of the following treatment arms: four cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy of IFRT; four cycles of ABVD + 20 Gy of IFRT; four cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP baseline ) + 30 Gy of IFRT; or four cycles of BEACOPP baseline + 20 Gy of IFRT. Results With a total of 1,395 patients included, the freedom from treatment failure (FFTF) at 5 years was 85.0%, overall survival was 94.5%, and progression-free survival was 86.0%. BEACOPP baseline was more effective than ABVD when followed by 20 Gy of IFRT (5-year FFTF difference, 5.7%; 95% CI, 0.1% to 11.3%). However, there was no difference between BEACOPP baseline and ABVD when followed by 30 Gy of IFRT (5-year FFTF difference, 1.6%; 95% CI, −3.6% to 6.9%). Similar results were observed for the radiotherapy question; after four cycles of BEACOPP baseline , 20 Gy was not inferior to 30 Gy (5-year FFTF difference, −0.8%; 95% CI, −5.8% to 4.2%), whereas inferiority of 20 Gy cannot be excluded after four cycles of ABVD (5-year FFTF difference, −4.7%; 95% CI, −10.3% to 0.8%). Treatment-related toxicity occurred more often in the arms with more intensive therapy. Conclusion Moderate dose escalation using BEACOPP baseline did not significantly improve outcome in early unfavorable HL. Four cycles of ABVD should be followed by 30 Gy of IFRT.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2010.29.8018

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2010

detail.hit.zdb_id: 2005181-5

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A European Organisation for Research and Treatment of Cancer Phase III Trial of Adjuvant Whole-Brain Radiotherapy Versus Observation in Patients With One to Three Brain Metastases From Solid Tumors After Surgical Resection or Radiosurgery: Quality-of-Life Results

Soffietti, Riccardo ; Kocher, Martin ; Abacioglu, Ufuk M. ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2013

In: Journal of Clinical Oncology Vol. 31, No. 1 ( 2013-01-01), p. 65-72

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 1 ( 2013-01-01), p. 65-72

Abstract: This phase III trial compared adjuvant whole-brain radiotherapy (WBRT) with observation after either surgery or radiosurgery of a limited number of brain metastases in patients with stable solid tumors. Here, we report the health-related quality-of-life (HRQOL) results. Patients and Methods HRQOL was a secondary end point in the trial. HRQOL was assessed at baseline, at 8 weeks, and then every 3 months for 3 years with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and Brain Cancer Module. The following six primary HRQOL scales were considered: global health status; physical, cognitive, role, and emotional functioning; and fatigue. Statistical significance required P ≤ .05, and clinical relevance required a ≥ 10-point difference. Results Compliance was 88.3% at baseline and dropped to 45.0% at 1 year; thus, only the first year was analyzed. Overall, patients in the observation only arm reported better HRQOL scores than did patients who received WBRT. The differences were statistically significant and clinically relevant mostly during the early follow-up period (for global health status at 9 months, physical functioning at 8 weeks, cognitive functioning at 12 months, and fatigue at 8 weeks). Exploratory analysis of all other HRQOL scales suggested worse scores for the WBRT group, but none was clinically relevant. Conclusion This study shows that adjuvant WBRT after surgery or radiosurgery of a limited number of brain metastases from solid tumors may negatively impact some aspects of HRQOL, even if these effects are transitory. Consequently, observation with close monitoring with magnetic resonance imaging (as done in the EORTC trial) is not detrimental for HRQOL.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2011.41.0639

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XA 52760

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XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2013

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