interim analysis of the german hd14 rct for limited stage hl

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Interim analysis of the German HD14 RCT for limited stage HL

Summary Author: Dr. C. Tom Kouroukis, MD MSc FRCPC

Date posted: January 30, 2009


GHSG HD14 Trial

• Treatment for limited stage Hodgkin’s Lymphoma (HL)• Standard therapy for LS HL is 4 cycles of chemo and IF-

RT based on the previous German HD8 trial• HD8 OS/FFTF 91%/83% at 5 years• Wanted to test BEACOPP as the chemo instead of

ABVD as a way of increasing dose intensity• 1216 patients with limited stage unfavourable HL

– Extranodal, large mediastinal mass, elevated ESR, at least 3 sites

– Clinical stage I, II A or IIB

Borchmann et al., ASH 2008: #367


GHSG HD14 Schema

R

ABVD x 4

escBEACOPPx 2

ABVD x 2

IF RT 30 Gy



GHSG HD14

• 1216 patients• 1010 patients evaluable• 4 cycles of ABVD versus 2 cycles of BEACOPP

and 2 cycles ABVD• All patients received involved field RT, 30 Gy• Third interim analysis• Balanced baseline characteristics



GHSG HD14 - results

ABVD x 4escBEACOPP x 2

ABVD x 2p

FFTF 3y90%

(87-93%)

96%

(94-98%)Sign.

Progression/

Early relapse5.9% 1.8% Sign.

Protocol adherence

98.8% 97.3%

Secondary cancers

8 pts 8 pts



GHSG HD14 - conclusions

• Superior FFTF for the BEACOPP/ABVD arm• Not sure about overall survival yet• No increased toxicity with BEACOPP/ABVD arm



GHSG HD14 - Canadian context

• Currently ABVD x 3 cycles and IF RT are standards in Canada

• In some institutions, ABVD alone might be given to patients with excellent early responses

• In this study, unfavourable limited stage patients were included, in some cases, large mediastinal masses or patients with IIB disease may be treated with full course chemotherapy (ie ABVD x 6) plus irradiation

interim analysis of the german hd14 rct for limited stage hl

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