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A randomized phase III study comparing paclitaxel-BEP (T-BEP) to standard BEP in patients with

intermediate prognosis germ cell cancer (GCC): An intergroup study of EORTC, German TCSG/AUO, MRC, and Spanish GCC group (EORTC 30983).

Authors: de Wit R. et al, ASCO 2011Abstract: 4509Reviewed by: Dr. Lori WoodDate posted: June 2011

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STUDY RATIONALE

• Since 1985, BEP chemotherapy is the gold standard treatment for all patients with metastatic GCTs– Cisplatin 20 mg/m2 d1-5– Etoposide 100 mg/m2 d1-5– Bleomycin 30 iu d2, d9, d16

• There are patients with intermediate and poor risk disease who still die of metastatic GCTs despite BEP

• There is a need to improve on standard BEP• Paclitaxel has shown activity in first-line and relapsed

GCTs• The idea was to bring Paclitaxel into the first-line setting

– 175 mg/m2 d1

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R

Treatment A: BEP + Paclitaxel x 4T-175 mg/m2 d1n=168GCSF

Treatment B:BEP x 4n=169

STUDY DESIGN

- IGCCC- Intermediate prognosis metastatic GCTs-Statistics: - 10% in 3-y PFS from 75% 85% - planned n=498 - closed with n=337 due to slow/poor accrual

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RESULTS

T-BEP BEP

n 168 169

Ineligible• good risk• poor risk

13

6

4

13

8

1

No Baseline Data 3 3

Eligible Patients 148 152

- Phase II accrual from November 1999 – March 2004. - Phase III accrual from March 2004 – August 2009 and then closed early. - Median follow-up = 5.3 years.

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RESULTS

T-BEP BEP HR p Value

N 168 169

Completed 4 Cycles 87.5% 92.3%

CR with Chemotherapy Only 65.1% 52.3%

CR with Chemotherapy/Surgery 70.4% 59.5% 0.055

3-y PFS (ITT) 79.4% 71.1%0.73

(0.47-1.13)0.153

3-y PFS (Eligible Patients) 82.7% 70.1%0.60

(0.37-0.97)0.03

3-y OS (ITT) 91.2% 89.8% 0.89 0.738

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STUDY COMMENTARY

• Primary endpoint of 3-y PFS was not met– But ineligible patients unbalanced between

the two arms

• Primary endpoint of eligible patients only – T-BEP better– 82.7% vs. 70.1% 3-y PFS

• Speculated that this was due to imbalance of ineligible patients between the two arms

• Two toxic deaths associated with T-BEP (1.3%)

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BOTTOM-LINE FOR CANADIAN MEDICAL ONCOLOGISTS

• Intriguing results but a positive trial only when data looked at eligible patients and not intention to treat analysis

• Given the great research question, it is hard to believe this study could not accrue and this fact really hurt this study

• I do not think we can incorporate these results into every day practice at this time