Abstract

Rituximab plus CHOP (R-CHOP) is the standard chemotherapy (CT) regimen for elderly patients (pts) with CD20 positive DLBCL. However, many pts aged 70 years (yrs) or more are often unable to received R-CHOP and the majority of them are excluded from clinical trials. Moreover, comprehensive geriatric assessment (CGA) has been demonstrated a useful instrument to predict the clinical outcome of elderly pts with cancer even if it has never been tested in a prospective way. Within the GOL (Gruppo Oncoematologico Linfomi) from June 2000 to March 2006 we started a phase II prospective study with the aim to evaluate the feasibility and activity of a CGA-driven CT for elderly pts with DLBCL. Rituximab was used in all pts after its introduction in the marketing in Italy (February 2002). Pts with no comorbidity received CHOP or R-CHOP; in pts with mild cardiopathy epirubicin was used instead of doxorubicin (CEOP or R-CEOP); in pts with moderate or severe cardiopathy the use of antracyclines was omitted (CVP or R-CVP); pts with diabetes didn't receive prednisone (CHO,CEO or R-CHO,R-CEO); pts with neuropathy received CHP or R-CHP or CEP or R-CEP (vincristine was omitted). Moreover, the dosage of CT was decided according to the CGA: pts with a good score of CGA (i.e. ADL=6 and IADL>6) received full doses of CT; pts with an intermediate score (ADL=5 and IADL>4) received 75% of the planned dose; pts with a poor score (ADL<5 and IADL<5) received 50% of the planned dose. All pts received prophylactic filgrastim. One hundred pts (41 males and 59 females) have been treated and no patient was excluded from this approach. The median age was 75 yrs (range 70–89) and stages III–IV were diagnosed in 51% of pts. Sixty-one per cent of pts received full doses of CT; 25% of pts received 75% of planned dose and 14% of pts 50% reduced dose of CT. Overall, 86% of pts received an antracycline (doxorubicin in 56% and epirubicin in 30%) and 54% of pts received rituximab plus CT. The following regimens were used: R-CHOP 22%, CHOP 16%, 75%-R-CHOP 10%, 75%-CHOP 8%, CEOP 11%, R-CEOP 4%, 75%-R-CEOP 9%, 75%-CEOP 6%. The remaining pts received CVP in 5% of cases and reduced R-CVP in 9% of cases. The toxicity was quite acceptable. Grade 3–4 neutropenia was observed in 29% of pts, mucositis in 13%, peripheral neuropathy in 9%, febrile neutropenia in 13%, cardiac toxicity in 3% and skin toxicity in 1%. Four toxic deats were observed (2 septic shock, 1 acute respiratory failure and 1 acute myocardial infarction). Overall, 76% of pts achieved a complete remission (CR) and with a median follow-up of 24 months (range 1–71 months) only 16% of them have relapsed. Seventy-three pts are alive and 63% are alive in CR. Our results demonstrated that a CGA-driven approach is feasible and highly active in elderly pts with DLBCL. Moreover this strategy allows a potentially curative approach to all pts with aggressive NHL avoiding both to under-treat elderly pts with a curable disease and to over-treat elderly pts with comorbidities.

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