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Industry: Email Alert RSS FeedTreatment of multiple myeloma in elderly people: long-term results in 178 patients
Age and Ageing, Sept, 1996 by Joan Blade, Montserrat Munoz, Montserrat Fontanillas, Jesus San Miguel, Antonio Alcala, Juan Maldonado, Carles Besses, Maria Jesus Moro, Javier Garcia-Conde, Ciril Rozman, Emili Montserrat, Jordi Estape
Keywords: Multiple myeloma, Elderly people, Prognosis, Chemotherapy.
Introduction
Multiple myeloma is an age-related malignant plasma cell disorder [1]. Less than 15% of patients are below 50 years old at diagnosis and this disease is very uncommon in patients under 40 years [2]. In most series, the median age of patients at diagnosis is about 65 years. Advanced age has been reported to be a negative prognostic factor in some series [3-8]. However, other studies have shown no effect of age on both response to treatment and survival [9-11].
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In the present study, the outcome of 178 multiple myeloma patients 70 years or older, from a multicentre series of 487, has been analysed. The main objectives were: (1) to compare the presenting features, response to therapy, and survival of elderly patients with those of patients under 70 years, (2) to compare the efficacy and toxicity of a combination chemotherapy regimen including six drugs with the combination of melphalan and prednisone, and (3) to evaluate whether response to treatment is associated with longer survival in elderly myeloma patients.
Patients and Methods
Patients and diagnostic criteria: From I January 1985, to 31 December 1989, 178 patients with symptomatic multiple myeloma aged 70 or more years were entered into a randomized trial of PETHEMA (Programme for the Study and Treatment of Haematological Malignancies, Spanish Society of Haematology). These patients form part of 487 patients included in a randomized trial published elsewhere [12]. Multiple myeloma was diagnosed following the criteria of the Chronic Leukemia-Myeloma Task Force [13]. Patients were stratified according to Durie and Salmon's staging system [14]. Patients with monoclonal gammopathy of undetermined significance [15] and smouldering myeloma were excluded from the study [16]. There was no age limitation for entering the protocol and the exclusion criteria were: active gastroduodenal ulcer, cardiac arrhythmia or heart failure, or patients considered to be terminally ill.
Treatment: Ninety-one patients were allocated melphalan and-prednisone (MP) (melphalan 9 mg/[m.sup.2] and prednisone 60 mg/[m.sup.2] orally from days 1 to 4). Eighty-seven patients were assigned alternating cycles of VCMP (vincristine 1 mg i.v. on day 1, cyclophosphamide 500 mg/[m.sup.2] i.v. on day 1, melphalan 6 mg/[m.sup.2] orally on days 1-4, and prednisone 60 mg/[m.sup.2] orally or parenterally on days 1-4) and VBAP (vincristine 1 mg i.v., BCNU and adriamycin 30 mg/[m.sup.2] each i.v. on day 1, and prednisone 60 mg/[m.sup.2] orally or parenterally on days 1-4). Cycles were administered at 4-week intervals. Evaluation was made after eight courses of therapy. Responding patients received eight additional cycles. Patients who died within the first 2 months from the initiation of treatment were considered as early deaths.
Criteria of response: Response to therapy was assessed according to the criteria of the Chronic Leukemia-Myeloma Task Force [13]. An objective response was defined as (1) a reduction of 50% or more in the M-component size, (2) improvement in the performance status by at least two grades, (3) a decrease of 50% or more in measured cross-sectional area of plasmacytomas, and (4) no increase in Iytic bone lesions and correction of anaemia, hypoalbuminaemia, and hypercalcaemia. Patients fulfilling all the above criteria, but with a decrease in the M-component size of less than 50% were considered as partial responders. When the criteria for objective or partial response were not met, the case was considered as a treatment failure.
Statistical methods: The chi-square test was used to assess the statistical significance of multiple comparisons. Survival times were calculated from the start of treatment. Survival curves were plotted according to the method of Kaplan and Meier [17] and statistically compared by means of the log-rank test [18]. To overcome the bias in favour of responders represented by the time necessary to detect the response when considered as an initial variable, the influence of the response to therapy on survival was assessed by the landmark method [19]. In this study, the landmark was situated at the time of response evaluation (i.e. 8 months after the initiation of treatment).
Results
Pretreatment characteristics: The sex, performance status, renal function, serum calcium, haemoglobin level, serum albumin, platelet count, percentage of bone marrow plasma cells, LDH, serum beta2-microglobulin level, clinical stage, and M-component type of the 178 older patients were similar to those of the 309 patients aged under 70 years.
Response to therapy and toxicity: The overall response rate (objective plus partial) was almost identical between patients younger than 70 years and the older population (57.7% vs.54.0%, p = NS). In addition, the proportion of early deaths was slightly less than 10% in both age groups and about one third of patients in each group did not respond to the initial chemotherapy. Considering the 178 older patients, 13 could not be evaluated for response for different reasons (Table I). The proportion of early deaths was similar in both treatment groups (8% and 9%). In the 86 evaluable patients treated with MP, the overall response rate was 50% (28% objective plus 22% partial response), while among the 79 patients who were given combination chemotherapy the overall response rate was 61% (44% objective plus 17% partial response) (p-NS).
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