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.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 717-717 ◽  
Author(s):  
Peter Borchmann ◽  
Volker Diehl ◽  
Helen Goergen ◽  
Horst Mueller ◽  
Rolf Peter Mueller ◽  
...  
Keyword(s):  
Risk Factors ◽  
Conflicts Of Interest ◽  
Remission Rate ◽  
Intensive Therapy ◽  
Final Analysis ◽  
Patient Characteristics ◽  
Combined Modality Treatment ◽  
Combined Modality ◽  
Involved Field ◽  
Involved Field Radiotherapy

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.

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

2010 ◽  
Vol 28 (27) ◽  
pp. 4199-4206 ◽  
Author(s):  
Hans Theodor Eich ◽  
Volker Diehl ◽  
Helen Görgen ◽  
Thomas Pabst ◽  
Jana Markova ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Intensive Therapy ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Standard Of Care ◽  
Hodgkin's Lymphoma ◽  
Combined Modality Treatment ◽  
Intensified Chemotherapy ◽  
Involved Field ◽  
Involved Field Radiotherapy

PurposeCombined-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 MethodsPatients 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 (BEACOPPbaseline) + 30 Gy of IFRT; or four cycles of BEACOPPbaseline+ 20 Gy of IFRT.ResultsWith 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%. BEACOPPbaselinewas 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 BEACOPPbaselineand 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 BEACOPPbaseline, 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.ConclusionModerate dose escalation using BEACOPPbaselinedid not significantly improve outcome in early unfavorable HL. Four cycles of ABVD should be followed by 30 Gy of IFRT.

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.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 716-716 ◽  
Author(s):  
Andreas Engert ◽  
Volker Diehl ◽  
Annette Pluetschow ◽  
Hans T. Eich ◽  
Richard Herrmann ◽  
...  
Keyword(s):  
Radiation Dose ◽  
Hodgkin Lymphoma ◽  
Early Stage ◽  
Final Analysis ◽  
Standard Of Care ◽  
Combined Modality Treatment ◽  
Who Grade ◽  
Significant Difference ◽  
Involved Field ◽  
Involved Field Radiotherapy

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.

Dose-Intensified Combined Modality Treatment with 2 Cycles of BEACOPP Escalated Followed by 2 Cycles of ABVD and Involved Field Radiotherapy (IF-RT) Is Superior to 4 Cycles of ABVD and IFRT in Patients with Early Unfavourable Hodgkin Lymphoma (HL): An Analysis of the German Hodgkin Study Group (GHSG) HD14 Trial

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 367-367 ◽  
Author(s):  
Peter Borchmann ◽  
Andreas Engert ◽  
Annette Pluetschow ◽  
Michael Fuchs ◽  
Jana Markova ◽  
...  
Keyword(s):  
Risk Factors ◽  
Overall Survival ◽  
Standard Treatment ◽  
Dose Intensity ◽  
Patient Characteristics ◽  
Primary Objective ◽  
Combined Modality Treatment ◽  
Test Statistic ◽  
Group Sequential ◽  
Combined Modality

Abstract Purpose: Combined modality treatment consisting of 4 cycles of chemotherapy and IF-RT is the standard treatment for early unfavourable HL. Overall survival (OS) and freedom from treatment failure (FFTF) in this group of patients was 91% and 83%, respectively, at 5 years in our prior HD8 study. Thus, the rationale for HD14 was to improve on these results by increasing dose intensity using BEACOPP escalated. Methods: Between January 2003 and January 2007, 1.216 patients aged 16–60 with untreated early unfavourable stage HL (CS I, IIA with one of the following risk factors: large mediastinal mass (a), extranodal disease (b), elevated ESR (c), or ≥ 3 nodal areas (d); IIB with risk factors c and d) were randomized to either 4 cycles of ABVD (arm A) or 2x BEACOPP escalated followed by 2x ABVD (arm B). All patients received 30Gy IF-RT after chemotherapy. Primary objective was the improvement of the FFTF. Here we present the results of the predefined 3rd interim analysis within the prespecified group sequential test design. Results: Of the 1.216 patients included, 1.010 were evaluable for this analysis. Patient characteristics were well balanced between both arms. At 3 years, the FFTF for arm A is 90% (95% CI: 87%–93%), and for arm B 96% (95% CI: 94%–98%). Since the observed inverse normal test statistic exceeds the critical level, the null hypothesis of equal FFTF in each arm can already be rejected. The improved FFTF is mainly due to differences in progression and early relapses (arm A 5.9% versus arm B 1.8%). Protocol adherence for chemotherapy was high and not different in both arms (arm A 98.8%, am B 97.3%). Though the chemotherapy-intensity was higher in the experimental arm, safety was comparable to the standard treatment. Secondary neoplasias occurred in 8 patients in each arm so far. Conclusion: Based on the significantly superior FFTF of the intensified therapy (2x BEACOPP escalated + 2x ABVD + IF-RT) compared to the prior standard (4x ABVD + IF-RT), this more aggressive treatment strategy will become the new standard for early unfavourable HL patients within the GHSG. Whether the improved FFTF translates into an improved overall survival must be awaited. Future strategies should aim at identification of those patient subgroups that profit most from this approach.

Retrospective Study of Standard R-CHOP Therapy in Localized DLBCL

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 1620-1620
Author(s):  
Naoto Tomita ◽  
Hirotaka Takasaki ◽  
Kazuho Miyashita ◽  
Shin Fujisawa ◽  
Eriko Ogusa ◽  
...  
Keyword(s):  
Risk Factors ◽  
Cell Lymphoma ◽  
Performance Status ◽  
B Cell Lymphoma ◽  
Local Irradiation ◽  
Cns Prophylaxis ◽  
Involved Field ◽  
Involved Field Radiotherapy ◽  
Chop Therapy ◽  
Observation Period

Abstract Abstract 1620 Few randomized prospective studies have been conducted on patients with localized DLBCL in the rituximab era. The SWOG 0014 study examined DLBCL patients treated with 3 cycles of R-CHOP followed by involved-field radiotherapy. Each of the patients had at least 1 of the 4 risk factors (nonbulky stage II, over 60 years of age, WHO performance status [PS] of 2, or elevated LDH), but showed 4-year progression-free survival (PFS) and 4-year overall survival (OS) rates of 88% and 92%, respectively. However, long-term observations showed that the PFS and OS curves did not plateau (Persky DO, et al. J Clin Oncol 2008). We retrospectively analyzed a series of patients with localized DLBCL treated with R-CHOP therapy alone. This study included 190 consecutive, untreated patients with localized DLBCL seen between 2003 and 2009 in 1 of the 7 participating hospitals. All the patients were scheduled to undergo primary therapy with 6 cycles of full-dose R-CHOP in 1 of the hospitals. Patients who required a dose reduction of more than 20% were excluded from the study, as were patients with special forms of DLBCL, such as intravascular lymphoma, primary mediastinal large B-cell lymphoma, and T-cell-rich B-cell lymphoma. Patients who achieved partial remission (PR) after the 4 initial cycles underwent a total of 8 R-CHOP cycles. Patients who did not achieve PR after the 4 initial cycles or those with disease progression at any time during the study underwent salvage therapy, and that time point was designated as the point at which the disease progression began. Additional local irradiation was allowed in patients with PR. Patients who received additional radiotherapy following CR in the decision of attending physicians were excluded from this study. Patients who achieved CR but who were initially at risk of central nervous system (CNS) involvement received 4 intrathecal doses of methotrexate (15 mg) and hydrocortisone (25 mg) for CNS prophylaxis. Central pathological reviews were not performed; only the individual institutional diagnoses were used. The study included 111 men and 79 women, with a median age at diagnosis of 63 years (range, 18–80 years). According to the IPI, 133 patients were classified as L; 49, as LI; 5, as HI; and 3, as H. Five patients received additional local irradiation after PR at the end of the R-CHOP therapy. CNS prophylaxis was performed in 15 patients who had an initial CNS risk and achieved CR. The median observation period for the living patients was 52 months. The responses to therapy were 180 CR, 8 PR, and 2 progression of disease (PD). The 5-year PFS and 5-year OS rates were 84% and 90%, respectively, and both plateaued (Figure 1). None of the patients experienced PD after 4 years of observation. Multivariate analysis revealed that the presence of bulky mass, which was evident in 18 patients, was an independent risk factor for PFS (P = 0.007, relative risk [RR] 3.5) and OS (P = 0.003, RR 5.8), along with poor performance status. During the observation period, 29 patients experienced PD. The progression sites included the primary sites in 15 patients, outside the primary sites in 10, and undetermined in 4. There were 16 deaths, 14 of which were due to the lymphoma. In 149 patients with at least one of the 4 risk factors used in the SWOG 0014 study, the 5-year PFS and 5-year OS rates were 86% and 94%, respectively. Six cycles of R-CHOP therapy alone were observed to be highly effective in attaining good survival results with plateaus. These results suggest that the “standard” strategy of 3 cycles of R-CHOP followed by involved-field radiotherapy for localized DLBCL should be replaced by R-CHOP alone. Disclosures: No relevant conflicts of interest to declare.

Involved Field Radiotherapy Versus No Further Treatment in Patients with Clinical Stages IA and IIA Hodgkin Lymphoma and a ‘Negative’ PET Scan After 3 Cycles ABVD. Results of the UK NCRI RAPID Trial

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 547-547 ◽  
Author(s):  
John Radford ◽  
Sally Barrington ◽  
Nicholas Counsell ◽  
Ruth Pettengell ◽  
Peter Johnson ◽  
...  
Keyword(s):  
Pet Imaging ◽  
Conflicts Of Interest ◽  
Early Stage ◽  
Pet Scan ◽  
Negative Score ◽  
The Uk ◽  
Involved Field ◽  
To Receive ◽  
Involved Field Radiotherapy ◽  
Negative Population

Abstract Abstract 547 In early stage HL abbreviated chemotherapy (ACT) followed by involved field radiotherapy (IFRT) is the current standard of care but some patients (pts) are probably cured by ACT alone. PET imaging has the potential to identify pts with an excellent prognosis after ACT and so provide the opportunity to avoid radiotherapy and reduce late treatment toxicity in these individuals. We present results of the RAPID trial evaluating PET response directed therapy in pts with previously untreated stages I and II HL, no B symptoms or mediastinal bulk. All pts taking part in RAPID received 3 cycles ABVD followed by a PET scan at one of fifteen quality controlled/assured PET Scan Centres across the UK. Acquired images were transmitted electronically to the Core Lab in London for central review. If the PET scan was reported ‘negative’ (score 1 or 2 on a 5 point scale), pts were randomised between IFRT and no further treatment (NFT). Those with a ‘positive’ PET scan (score 3, 4 or 5) had a 4th cycle ABVD and IFRT. This non-inferiority trial required 400 PET negative pts to be randomised for exclusion of a ≥7% difference in 3-year progression-free survival (PFS) from 95% in the IFRT arm, with 90% power and 5% significance level. 602 pts (321 male, 281 female; median age 34 years) with newly diagnosed, stages IA/IIA HL were registered into the RAPID trial between October 2003 and August 2010. Following 3 cycles ABVD, 571 pts had a PET scan of which 426 (74.6%) were classified as PET negative (score 1, n=301; score 2, n=125). 420 PET negative pts were randomised to receive IFRT (n=209) or NFT (n=211); 6 PET negative pts were not randomised (pt choice, n=3, clinician choice, n=2; error, n=1). 22 of 209 pts randomised to receive IFRT did not receive this treatment because 16 pts (PET score 1, n=14; PET score 2, n=2) declined after they became aware of the randomisation decision, 5 had died and 1 developed pneumocystis jiroveci pneumonia. After a median follow-up of 45.7 months from randomisation, 384 of 420 (91.4%) PET negative pts are alive and progression-free, 29 (6.9%) are alive and have progressed and 7 (1.7%) have died giving a combined 3-year PFS of 92.2% and overall survival (OS) of 98.3% in the randomised population. In the IFRT arm of the randomised PET negative population, 194 pts are alive and progression-free, 9 have progressed, and 6 have died (pneumonitis, n=2; HL, n=1; cardiovascular disease, n=1; intracerebal haemorrhage, n=1; angioimmunoblastic T cell lymphoma, n=1). In the NFT arm 190 pts are alive and progression-free, 20 have progressed, and 1 has died (bronchopneumonia, n=1). 3-year PFS is 93.8% IFRT versus 90.7% NFT (risk difference −2.9%, 95% CI −10.7 to 1.4%; the lower limit marginally exceeds the maximum allowable difference of −7%) and 3-year OS is 97.0% IFRT versus 99.5% NFT. For the 145 PET positive pts who received a 4thcycle ABVD and IFRT, 126 are alive and progression-free, 11 progressed, and 8 died to give a 3-year PFS of 85.9% and OS of 93.9% from registration. These results are summarized in the Table. These results show that in early stage HL, pts with a negative PET after 3 cycles of ABVD have an excellent prognosis without any further treatment. The 3-year PFS is slightly higher in the PET negative pts receiving IFRT (93.8% vs 90.7%), where a non-inferiority margin of 7% was deemed acceptable. We conclude that in stages IA/IIA HL, RT is unnecessary in the 75% of pts who become PET negative after 3 cycles ABVD. Such a response adapted approach based on centrally reviewed PET imaging reduces treatment time and costs, improves tolerability and most importantly removes the burden of early and late toxicity of radiotherapy from the PET negative population. Outcomes by PET status after 3 cycle ABVD and subsequent treatment Disclosures: No relevant conflicts of interest to declare.

Dose-Intensification in Early Unfavorable Hodgkin's Lymphoma: Final Analysis of the German Hodgkin Study Group HD14 Trial

2012 ◽  
Vol 30 (9) ◽  
pp. 907-913 ◽  
Author(s):  
Bastian von Tresckow ◽  
Annette Plütschow ◽  
Michael Fuchs ◽  
Beate Klimm ◽  
Jana Markova ◽  
...  
Keyword(s):  
Hodgkin’S Lymphoma ◽  
Progression Free Survival ◽  
Final Analysis ◽  
Hodgkin's Lymphoma ◽  
Tumor Control ◽  
Combined Modality Treatment ◽  
The Difference ◽  
Intensified Chemotherapy ◽  
Involved Field

Purpose In patients with early unfavorable Hodgkin's lymphoma (HL), combined modality treatment with four cycles of ABVD (adriamycin, bleomycin, vinblastine, and dacarbazine) and 30 Gy involved-field radiotherapy (IFRT) results in long-term tumor control of approximately 80%. We aimed to improve these results using more intensive chemotherapy. Patients and Methods Patients with newly diagnosed early unfavorable HL were randomly assigned to either four cycles of ABVD or an intensified treatment consisting of two cycles of escalated BEACOPP (bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, and prednisone) followed by two cycles of ABVD (2 + 2). Chemotherapy was followed by 30 Gy IFRT in both arms. The primary end point was freedom from treatment failure (FFTF); secondary end points included progression-free survival (PFS) and treatment-related toxicity. Results With a total of 1,528 qualified patients included, the 2 + 2 regimen demonstrated superior FFTF compared with four cycles of ABVD (P < .001; hazard ratio, 0.44; 95% CI, 0.30 to 0.66), with a difference of 7.2% at 5 years (95% CI, 3.8 to 10.5). The difference in 5-year PFS was 6.2% (95% CI, 3.0% to 9.5%). There was more acute toxicity associated with 2 + 2 than with ABVD, but there were no overall differences in treatment-related mortality or secondary malignancies. Conclusion Intensified chemotherapy with two cycles of BEACOPP escalated followed by two cycles of ABVD followed by IFRT significantly improves tumor control in patients with early unfavorable HL.

Reduction of Combined Modality Treatment Intensity in Early Stage Hodgkin’s Lymphoma: Interim Analysis of the HD 10 Trial of the GHSG.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 1307-1307 ◽  
Author(s):  
Volker Diehl ◽  
C. Brillant ◽  
A. Engert ◽  
J. Wolf ◽  
L. Nogova ◽  
...  
Keyword(s):  
Risk Factors ◽  
Complete Remission ◽  
Interim Analysis ◽  
Standard Treatment ◽  
Early Stage ◽  
Treatment Intensity ◽  
Combined Modality Treatment ◽  
Who Grade ◽  
Early Stage Disease ◽  
Combined Modality

Abstract Background: Combined modality treatment of chemotherapy (usually ABVD) followed by involved field irradiation (IF) is today a standard treatment regimen for early stage Hodgkin′s lymphoma (HL)in stages I-II without risk factors in most study groups. The complete remission rates achieved with this treatment strategy are more than 90%. However, the question arises, whether treatment intensity of chemotherapy, radiotherapy or both may be further reduced in these patients. Aim: In the HD10 trial of the GHSG, reduction of ABVD cycles as well as reduction of IF- RT dose were investigated. Methods: Patients were randomized between 4 cycles of ABVD followed by 30 Gy IF radiotherapy as standard treatment (arm A), 4 cycles ABVD + 20 Gy IF (arm B), 2 cycles ABVD + 30 Gy IF (arm C) and 2 cycles ABVD + 20 Gy IF (arm D). Results: Between May 1998 and May 2002, 1131 HL patients with early stage disease (CS I,II without risk factors) were randomized. 847 patients (75%) were evaluable for this second interim analysis performed in August 2003. Patient characteristics were well balanced between the treatment arms. In total, 98.4% of the patients reached complete remission. Progressive disease or no change were observed in 0.9% of patients, relapse rate was 2.5%. In total, thirteen patients died during the study (1,5%). During chemotherapy there were 19% leukopenia as the most common WHO grade III/IV toxicity (4xABVD: 22 %, 2xABVD: 15%). Radiotherapy was well tolerated with dysphagia in 2.3%. Altogether ten secondary neoplasias were seen: 1AML, 4 NHL and 5 solid tumors. After a median observation time of two years, overall survival (OS) and freedom from treatment failure (FFTF) rates were 98.5% and 96.6%, respectively. No statistical differences in FFTF and OS were detected between 4xABVD and 2xABVD. In addition, there was no statistical difference between the different doses of radiotherapy (30Gy vs. 20Gy). Conclusions: Since only few events were observed, the results of this interim analysis can be interpreted as a trend that therapy intensity in combined modality treatment of early stage might be further reduced in terms of the number of chemotherapy cycles as well as the radiotherapy dose, even in IF-RT setting.

Evaluation of Early Stage Hodgkin’s Lymphoma Treatment: Two Decades of Progress.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 4581-4581
Author(s):  
Eyad F. Alsaeed ◽  
Rajiv Samant ◽  
Gallant Victor ◽  
Lother Huebsch ◽  
Wayne Kendal
Keyword(s):  
Overall Survival ◽  
Treatment Modality ◽  
Hodgkin’S Lymphoma ◽  
Early Stage ◽  
Disease Free Survival ◽  
Hodgkin's Lymphoma ◽  
Combined Modality Treatment ◽  
Combined Modality ◽  
Involved Field ◽  
Disease Free

Abstract Introduction The treatment of early stage Hodgkin’s lymphoma is controversial. Radiotherapy alone, chemotherapy alone or a combination of radiotherapy and chemotherapy are all considered effective options. Purpose The purpose of this study is to review the treatment approaches and outcomes used for early stage Hodgkin’s lymphoma over the past two decades at ORCC Methods Retrospective chart review of all patients with stage IA /IIA treated from 1984–2002 was performed. Patients were separated into three groups according to initial treatment modality: radiation alone (Rads), chemotherapy alone (Chemo), or combined modality (Combined). Disease-free survival and overall survival were estimated using the Kaplan-Meier analysis. Result Between May 1984 and January 2003, 172 patients with newly diagnosed Hodgkin’s lymphoma (28% stage 1A, 72% stage 2A) were seen at our centre. Treatment was as follows: 49% Rads, 13% Chemo and 38% Combined. The median age was 33.7 years (range: 17 – 82 years) and the median follow-up of 73 months (range: 3 – 204 months). The 5-year disease free and overall survival rates for the entire group were 90% and 96 % respectively. The 5-year disease-free and overall survival by treatment modality was: Rads 87% and 93 %; Chemo 80 % and 100 %; Combined 97 % and 98%. In the Combined group, there was no difference in outcome between patients receiving involved-field radiation and those receiving extended-field radiotherapy. The relapse rate in a patient who received abbreviated chemotherapy and greater than four cycles was 4.3% (1 out of 23) and 2.4% (1 out of 41) respectively. The incidence of acute Grade 3 and 4 toxicities were 9 % and 0.5% respectively. Conclusions Our data confirms the excellent prognosis of early stage Hodgkin’s lymphoma with all the approaches used at our centre. At present, we favour combined modality treatment with involved-field radiotherapy and our results support its continued use.

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