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Radiotherapy is Unnecessary in Elderly Patients With Localized Aggressive Non-Hodgkin's Lymphoma: Results of the GELA LNH 93-4 Study

Reviewer: Walter Sall, MD
OncoLink
Ultima Vez Modificado: 9 de diciembre del 2002

Presenter: Georges Fillet
Presenter's Affiliation: Hematology, CHU - Sart Tilman
Type of Session: Scientific

Background

• CHOP plus local radiotherapy is considered the standard treatment for localized, aggressive Non-Hodgkin's Lymphoma (NHL). It has been shown to be superior to eight cycles of CHOP alone (Miller, NEJM, 1998).
• To date, there has been no prospective, randomized trial comparing chemotherapy alone to the identical chemotherapy with involved field radiotherapy (IFRT) in this patient population.

Materials and Methods

• The LNH 93-4 trial is a prospective, randomized trial of four cycles of CHOP vs. four cycles of CHOP followed by 40 Gy IFRT.
• Radiation fractionation was 1.8Gy daily. Chemotherapy was given every three weeks.
• From March, 1993 to June, 2000, 520 patients were enrolled at 49 centers.
• Patients were > 60 years old, had Stage I or II disease, normal LDH, ECOG performance status <2, with aggressive histology. Patients were stratified by bulk; < or > 10cm.
• Median patient age was 68 years. 66% were stage I, 70% ECOG 0, 9% bulky disease. All patient characteristics were well balanced between groups.
• Median follow-up was 55 months.

Results

• Complete Response (CR) rate was 92% without radiation (RT) vs. 89% with RT.
• 5 year Event Free Survival (EFS) was 69% without RT vs. 64% with RT (p=NS).
• 5 year Overall Survival (OS) was 78% without RT vs. 68% with RT, (p=NS).
• 5 year locoregional failure was 45% without RT vs. 23% with RT.
• There was a trend towards decreased OS and EFS in irradiated patients age 70 or older (p=0.03).

Author's Conclusions

• This is the first prospective, randomized trial comparing chemotherapy alone to chemotherapy plus radiation in localized, aggressive NHL.
• IFRT does not appear to improve CR rate, EFS or OS at 5 years.
• For patients older than 69, IFRT may have a negative impact on outcomes.
• However, the overall 5 year EFS of 67% in this study does not compare favorably with other modern trials of chemotherapy alone in this disease. For this reason, GELA no longer recommends CHOP for localized agressive lymphoma.

Clinical/Scientific Implications

This trial provides evidence to support the use of chemotherapy alone in the treatment of aggressive, localized NHL in the elderly population. The addition of IFRT did improve locoregional recurrence rates, but this did not translate into improved EFS or OS. In fact, there was a trend towards decreased EFS and OS in the subgroup older than 69 years treated with radiation. One can't ignore the relatively low overall 5 year EFS seen in this trial. It may reflect the inadequacy of CHOP chemotherapy in this patient population. Perhaps the efficacy of the chemotherapy was not enough to allow patients to realize the benefit of the improved local control from RT. Further trials of more modern chemotherapy regimens with and without RT are necessary to answer these questions.

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