BACKGROUND: Introduction of the monoclonal antibody rituximab to chemotherapy regimens has substantially improved disease-free and overall survival in patients with non-Hodgkin lymphomas (NHL). The short-term safety of this drug has been widely reported, but there are few data on long-term safety, which suggests that these patients require prolonged follow-up. AIM OF THE REVIEW: To review the literature on follow-up models, with a focus on the safety of rituximab therapy for diffuse large B-cell lymphoma and follicular lymphoma. METHOD: The Cochrane Library, Embassy, Lilacs, Medline, and Scirus databases were searched for systematic reviews and randomized controlled trials. Furthermore, textbooks and journals on pharmaceutical care and institutional websites were searched for patient management recommendations. The outcomes were follow-up models and grade 3, 4, and 5 adverse reactions. RESULTS: Five systematic reviews and eight clinical trials or updates describing patient follow-up or reporting adverse reactions were identified. Only one systematic review and seven clinical trials reported follow-up routines for patients receiving rituximab, including information on staging, frequency of reassessment, and laboratory tests, as well as pre-infusion care and management of acute or delayed adverse reactions. Five systematic reviews and four clinical trials reported data on statistically significant adverse reactions (fever, leukopenia, infection). Four guidelines or institutional protocols for treatment and follow-up were identified, as well as seven studies describing experiences in the implementation of pharmaceutical care for oncology patients, but none were specifically focused on follow-up of patients receiving rituximab for NHL. CONCLUSION: Although some systematic reviews and clinical trials contain guidance on follow-up of patients receiving rituximab for NHL, there are no validated strategies for systematic follow-up of these patients with a focus on safety. As there are few data on long-term safety profile of these novel treatments, monitoring strategies should be developed and implemented to ensure safe and optimized use of drugs recently added to the therapeutic arsenal of clinical oncology.
BACKGROUND: Introduction of the monoclonal antibody rituximab to chemotherapy regimens has substantially improved disease-free and overall survival in patients with non-Hodgkin lymphomas (NHL). The short-term safety of this drug has been widely reported, but there are few data on long-term safety, which suggests that these patients require prolonged follow-up. AIM OF THE REVIEW: To review the literature on follow-up models, with a focus on the safety of rituximab therapy for diffuse large B-cell lymphoma and follicular lymphoma. METHOD: The Cochrane Library, Embassy, Lilacs, Medline, and Scirus databases were searched for systematic reviews and randomized controlled trials. Furthermore, textbooks and journals on pharmaceutical care and institutional websites were searched for patient management recommendations. The outcomes were follow-up models and grade 3, 4, and 5 adverse reactions. RESULTS: Five systematic reviews and eight clinical trials or updates describing patient follow-up or reporting adverse reactions were identified. Only one systematic review and seven clinical trials reported follow-up routines for patients receiving rituximab, including information on staging, frequency of reassessment, and laboratory tests, as well as pre-infusion care and management of acute or delayed adverse reactions. Five systematic reviews and four clinical trials reported data on statistically significant adverse reactions (fever, leukopenia, infection). Four guidelines or institutional protocols for treatment and follow-up were identified, as well as seven studies describing experiences in the implementation of pharmaceutical care for oncology patients, but none were specifically focused on follow-up of patients receiving rituximab for NHL. CONCLUSION: Although some systematic reviews and clinical trials contain guidance on follow-up of patients receiving rituximab for NHL, there are no validated strategies for systematic follow-up of these patients with a focus on safety. As there are few data on long-term safety profile of these novel treatments, monitoring strategies should be developed and implemented to ensure safe and optimized use of drugs recently added to the therapeutic arsenal of clinical oncology.
Authors: Thomas J Smith; James Khatcheressian; Gary H Lyman; Howard Ozer; James O Armitage; Lodovico Balducci; Charles L Bennett; Scott B Cantor; Jeffrey Crawford; Scott J Cross; George Demetri; Christopher E Desch; Philip A Pizzo; Charles A Schiffer; Lee Schwartzberg; Mark R Somerfield; George Somlo; James C Wade; James L Wade; Rodger J Winn; Antoinette J Wozniak; Antonio C Wolff Journal: J Clin Oncol Date: 2006-05-08 Impact factor: 44.544
Authors: Marinus H J van Oers; Martine Van Glabbeke; Livia Giurgea; Richard Klasa; Robert E Marcus; Max Wolf; Eva Kimby; Mars van t Veer; Andrej Vranovsky; Harald Holte; Anton Hagenbeek Journal: J Clin Oncol Date: 2010-05-03 Impact factor: 44.544
Authors: P Feugier; A Van Hoof; C Sebban; P Solal-Celigny; R Bouabdallah; C Fermé; B Christian; E Lepage; H Tilly; F Morschhauser; P Gaulard; G Salles; A Bosly; C Gisselbrecht; F Reyes; B Coiffier Journal: J Clin Oncol Date: 2005-05-02 Impact factor: 44.544
Authors: Robert Marcus; Kevin Imrie; Andrew Belch; David Cunningham; Eduardo Flores; John Catalano; Philippe Solal-Celigny; Fritz Offner; Jan Walewski; Joäo Raposo; Andrew Jack; Paul Smith Journal: Blood Date: 2004-10-19 Impact factor: 22.113
Authors: Michele Ghielmini; Shu-Fang Hsu Schmitz; Sergio B Cogliatti; Gabriella Pichert; Jörg Hummerjohann; Ursula Waltzer; Martin F Fey; Daniel C Betticher; Giovanni Martinelli; Fedro Peccatori; Urs Hess; Emanuele Zucca; Roger Stupp; Tibor Kovacsovics; Claudine Helg; Andreas Lohri; Mario Bargetzi; Daniel Vorobiof; Thomas Cerny Journal: Blood Date: 2004-02-19 Impact factor: 22.113
Authors: H Schulz; J Bohlius; N Skoetz; S Trelle; T Kober; M Reiser; M Dreyling; M Herold; G Schwarzer; M Hallek; A Engert Journal: Cochrane Database Syst Rev Date: 2007-10-17