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Elderly patients tolerated reduced-intensity, related haploidentical BMT followed by high-dose cyclophosphamide
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NEW ORLEANS — Reduced-intensity, related haploidentical blood or marrow transplantation followed by high-dose cyclophosphamide does not carry prohibitive toxicities in older patients, according to a study presented at the ASH Annual Meeting and Exposition.
Researchers determined that patients aged 60 to 75 years achieved similar safety and efficacy outcomes as those in their 50s.
Yvette Kasamon, MD, associate professor of oncology and medicine at Johns Hopkins University, and colleagues retrospectively evaluated outcomes of this regimen in 273 patients aged 50 to 75 years (median age, 61 years). The majority of patients (n=154; 56%) were aged 60 years or older, and 27 (10%) were aged 70 to 75 years.
Patients underwent haploidentical blood or marrow transplantation (BMT) as a result of having no matched donors. However, there has been limited information available on haploidentical BMT outcomes in patients of this age group, according to background information provided by researchers.
“Hematologic malignancies disproportionately affect older patients, who have historically also suffered higher risks of graft-versus-host disease (GVHD) and of end-organ toxicity,” Kasamon said during a press conference. “However, there have been recent significant improvements in how we perform half-matched transplants. The regimen that our program is based upon uses high-dose cyclophosphamide after transplant to help prevent GVHD and graft rejection.”
Eligible patients had an ECOG performance status of 0, 1 or 2, a left ventricular ejection fraction ≥35%, adequate pulmonary and renal function, and no uncontrolled infection.
Diagnoses included lymphoma in 153 patients (56%), acute leukemia or lymphoblastic lymphoma in 76 patients (32%), and myelodysplastic syndrome in 20 (7%).
Forty-one patients (15%) had previously undergone autologous transplantation and
51% had a comorbidity index score that was high risk.
According to the Disease Risk Index categorization, 32 patients (12%) were low risk, 197 (72%) were intermediate risk and 44 (16%) were high risk.
In most cases, patients received fludarabine, cyclophosphamide and 200 cGy total body irradiation for conditioning, a T-cell replete bone marrow graft, then high-dose post-transplantation cyclophosphamide (50 mg/kg/day on days 3 and 4), mycophenolate mofetil and tacrolimus.
Median follow-up was 2.1 years (range, ˂1-7.9 years) in event-free patients.
The 2-year survival estimates were 39% (95% CI, 32-44) for PFS and 53% (95% CI, 47-60) for OS. The median time to neutrophil recovery was 16 days and the median time to platelet recovery was 26 days.
Twelve percent of evaluable patients had graft failure, usually with recovery of their own bone marrow.
The estimated risk of nonrelapse mortality was 11% (95% CI, 7-14) by day 180 and 14% (95% CI, 10-19) by 1 year. The estimated GVHD risks were 32% for grade 2-4 acute GVHD and 3% for grade 3-4 acute GVHD. The estimated risk for chronic GVHD at 1 year was 12%.
The researchers found no statistically significant association between older age and overall outcomes. Estimated 2-year PFS was similar among patients in their 50s (39%), 60s (36%), and 70s (39 %; P=.9). Estimated 2-year OS rates for patients in their 50s (51%), 60s (56%), and 70s (44%; P=.9) also were similar.
Overall, 2-year probability for PFS was 39% (95% CI, 32-44), and 2-year probability for OS was 53% (95% CI, 47-60).
“The practice-changing implications of this study are two-fold,” Kasamon said. “Number one, it demonstrates that with recent advances, haploidentical transplants are a very reasonable consideration for patients who don’t have matched donors but who are in desperate need of a transplant. Number two, based on these data, we recently lifted our upper age limit for reduced-intensity transplants at Johns Hopkins. Instead, we look at performance status and functioning. Older age is no longer considered a barrier in our institution.”
For more Information:
Kasamon YL. Abstract #158. Presented at: ASH Annual Meeting and Exposition; Dec. 7-10, 2013; New Orleans.
Disclosure: The researchers report no relevant financial disclosures.