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Blood, 1 February 2002, Vol. 99, No. 3, pp. 856-862
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Monitoring of minimal residual disease after CHOP and rituximab
in previously untreated patients with follicular lymphoma
Alessandro Rambaldi,
Manuela Lazzari,
Cristina Manzoni,
Emanuela Carlotti,
Luca Arcaini,
Michele Baccarani,
Tiziano Barbui,
Carlo Bernasconi,
Giuseppe Dastoli,
Giovanna Fuga,
Enrica Gamba,
Livio Gargantini,
Valter Gattei,
Francesco Lauria,
Mario Lazzarino,
Franco Mandelli,
Enrica Morra,
Alessandro Pulsoni,
Michela Ribersani,
Pier Luigi Rossi-Ferrini,
Maurizio Rupolo,
Sante Tura,
Vittorina Zagonel,
Francesco Zaja,
PierLuigi Zinzani,
Gigliola Reato, and
Robin Foa
From the Divisione di Ematologia, Ospedali Riuniti
Bergamo; Oncologia Medica B e Nucleo di Ricerca Clinica e
Laboratoristica in Ematologia, Centro di Riferimento Oncologico IRCCS
Aviano; Cattedra di Ematologia Università di Pavia; Divisione di
Ematologia Ospedale Niguarda Milano; Cattedra di Ematologia
Università di Udine; Cattedra di Ematologia Università di
Firenze, Cattedra di Ematologia Università di Siena; Istituto di
Ematologia e Oncologia Medica Seragnoli, Università di Bologna;
Roche SpA, Monza; Dipartimento di Scienze Biomediche ed Oncologia
Umana, Università di Torino; and Dipartimento di Biotecnologie
Cellulari ed Ematologia, Università `La Sapienza', Rome, Italy.
Minimal residual disease (MRD) following sequential administration
of CHOP and rituximab was studied in previously untreated patients with
follicular lymphoma. At diagnosis, the presence of
Bcl-2/IgH-positive cells in the peripheral blood (PB) and/or bone
marrow (BM) was demonstrated in all patients (n = 128) by polymerase
chain reaction (PCR) analysis. Patients who achieved a clinical
response following CHOP but remained PCR-positive were eligible for
rituximab (375 mg/m2 intravenously, weekly for 4 weeks).
After CHOP, 57% achieved a complete response (CR), 37% a partial
response (PR), and 6% were nonresponders (NR). At this stage, patients
proving PCR-negative (n = 41) or failing to achieve a clinical
response (n = 8) were excluded from rituximab treatment.
Seventy-seven patients received rituximab and entered a scheduled MRD
follow-up program. At the first molecular follow-up (+12 weeks), 59%
had converted to PCR negativity in the BM and PB, with a further
increase documented at the second control (+28 weeks) with 74% PCR
negative. At the last molecular follow-up (+44 weeks), 63% of the
patients remained PCR negative. At 3 years, the estimated overall
survival of all patients is 95% (95% confidence interval [CI],
86-98). For patients achieving PCR-negative status following CHOP and
therefore excluded from rituximab treatment, freedom from recurrence
(FFR) was 52% (95% CI, 28-71). For patients treated with rituximab, a
durable PCR-negative status was associated with a better clinical
outcome since FFR was 57% (95% CI, 23-81) compared with 20% (95%
CI, 4-46) in patients who never achieved or lost the molecular
negativity (P < .001).
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