A Prospective Study of Cardiotoxicity In Non-Hodgkin Lymphoma Patients with RAPID-Infusion Rituximab

Background. Prospective study based on measuring the left ventricular ejection function (LVEF) of lymphoma patients treated with rapid infusion Rituximab (one hour). Patients and Methods. 42 patients with non-Hodgkin lymphoma were treated with rapid infusion Rituximab-based chemotherapy (mostly CHOP-R). Basal LVEF was measured before chemotherapy and every six months after treatment. Results. An average of 6.5 infusions per patient were administered (total of 273 infusions). Twenty-four (57%) patients had at least one cardiovascular risk factor. In 13 patients (31%) we observed a decreased in the post-treatment LVEF of over 10%. Patients (3) with drop > 10% recovered normally, but when LVEF decreased by over 15% (6 patients), no one recovered until normal level. None of them developed clinical congestive failure. Conclusion. Rapid infusion Rituximab added to chemotherapy does not cause clinical cardiac toxicity. Patients recover LVEF when it decreased less than 15%.

Prolongation of TTP by maintenance therapy with PLD in a multicenter phase III randomized trial following standard chemotherapy for MBC: GEICAM 2001–01 study

1007 Background: We had previously shown that sequential A→T is a reference treatment as first-line CT for MBC patients (pt) (JCO 2004, (22), 2587–2593). However, responses are short-lived and time to progression (TTP) is also short. Maintenance chemotherapy (MCT) with LPD could improve TTP without relevant additional toxicity. Methods: All pt received an induction CT with 6 cycles (cy) of A→T. Pt with a complete or partial response (CR, PR), or stable disease (SD) were randomly assigned to either LPD (40 mg/m2 q4wk × 6 cy) or observation (O) from May 2002 to Dec 2006. Eligible pt had adequate bone marrow, renal, hepatic and cardiac functions (by left ventricular ejection fraction, LVEF). The study hypothesis assumed a median TTP since start of induction CT in O arm of 10.5 months (m), and a prolongation of TTP of 66% with MCT. Therefore, 154 pt (77 per arm) were necessary (one-sided a and 1-β errors of 0.01 and 0.8). Results: Pt accrual was completed in December 06. 122 and 136 pt (60/66 in LPD vs. 62/70 in O) are currently evaluable for efficacy and safety. Median age was 57 yr (30–74). Status disease in pt assigned to LPD vs. O: 2 (3%) vs. 6 (9%) of pt had CR, 31 (47%) vs. 43 (61%) had PR; 33 (50%) vs. 21 (30%) had SD. 291 cy of LPD were administered (median 6, range 0–6). Neither relevant LVEF decrease nor clinical congestive failure were seen. Nausea/vomiting and alopecia incidence was negligible. G3 hand-foot syndrome was present in 3 pt/3 cy (5/1%). Median TTP in LPD arm was 16.04 m (14.06–18.02), vs. 9.96 m (8.87–11.05) in O arm, p=0.0001. Conclusion: Maintenance therapy with LPD significantly prolongs TTP in MBC pt after a first-line CT without significant clinical toxicity. No significant financial relationships to disclose.

Questions & Answers

The AMA Guides to the Evaluation of Permanent Impairment (AMA Guides), Chapter 3, The Heart and Aorta, is used to rate impairment in patients with coronary disease. Note that the four “functional classes” of the New York Heart Association, which are discussed in the chapter, should not be confused with the four classes used to rate impairment due to coronary heart disease. Treadmill testing of maximal exercise ability is a traditional measurement to help the evaluator place an individual in an impairment rating class. Class 1 impairment rarely is used in rating workers’ compensation impairment, and the presence of small (asymptomatic) coronary artery blockages that may progress is the justification for considering these individuals impaired even in the absence of symptoms. Classes 2, 3, and 4 describe the impairment of individuals with objectively documented symptomatic coronary disease. Class 2 impairment describes individuals who have no symptoms or who manage them with diet or medication and can achieve 90% of predicted maximal heart rate during exercise testing without specific signs of ischemia. Class 3 impairment describes individuals who have symptoms of congestive failure or angina with moderately heavy activity, and Class 4 includes individuals who have symptoms during ordinary activity. To give guidance in this process, a series of clinical examples follows the description of each class.