VISTA Final Analysis Upholds Survival Benefit of Bortezomib at 5 Years

February 2012 Vol 5, No 1, Special Issue - Multiple Myeloma, Multiple Myeloma
Caroline Helwick
Caroline Helwick

The final analysis of the phase 3 VISTA trial upheld a persistent and significant survival benefit for bortezomib in patients with previously untreated multiple myeloma.  

Of the 655 patients in VISTA, those treated with bortezomib lived an average of 13.3 months longer than those receiving a regimen lacking this agent, VISTA investigator Jesús F. San Miguel, MD, PhD, of the Hospital Clinico Universitario, Salamanca, Spain, reported.

“An overall survival [OS] benefit was seen across multiple prespecified patient subgroups and was maintained after 5 years’ follow-up and despite substantial use of novel agent–based salvage therapies,” said Dr San Miguel.

Data from the initial report of this international phase 3 trial showed that nine 6-week cycles of the bortezomib, melphalan, and prednisone (VMP) regimen were superior to the melphalan and prednisone (MP) regimen in patients with previously untreated multiple myeloma. At 36.7 months of follow-up, a second analysis confirmed a continued OS benefit. The current report was the final updated OS analysis after 5 years of follow-up, which includes data on 95% of the original cohort.

The 5-year follow-up also found no association between bortezomib treatment and the development of second primary cancers, at least above and beyond the incidence of cancer in the general healthy population. Since reports surfaced at ASH last year that lenalidomide seemed to be associated with a higher risk for second malignancies, studies of myeloma therapies all examine this potential risk.

Dr San Miguel said that based on the findings of no excess cancers, he is convinced that the long-term use of bortezomib is “completely safe.”

5-Year Mortality Risk Reduced by 31%
Mortality risk was reduced by 31% with the addition of bortezomib to the treatment regimen, despite the significant use of subsequent therapy once the disease progressed.

Median OS was 56.4 months after treatment with VMP versus 43.1 months with MP, amounting to an absolute benefit of 13.3 additional months of life across all subgroups (P = .004). The OS rate at 5 years was 46.0% with VMP versus 34.4% with MP, Dr San Miguel said.

Virtually all subgroups benefited significantly from the addition of bortezomib, including:

  • Older patients age ≥75 years, who had a 29% reduction in risk of death
  • Patients with International Staging System stage III disease, who had a 23% risk reduction
  • Patients with creatinine clearance <60 mL/min, who had a 30% risk reduction.

Only the small subgroup of patients with documented high-risk cytogenetics had no additional benefit from bortezomib.

Bortezomib also added 8 additional months to the time before the next treatment was required, and extended the treatment-free interval by almost 8 months (P <.001 for both).

As for the best time to prescribe bortezomib to previously untreated patients, Dr San Miguel noted that patients who received bortezomib as first-line treatment had longer OS than those who received bortezomib or other therapies in subsequent treatment lines. “These findings demonstrate the importance of providing optimal first-line treatment incorporating bortezomib,” he said, “rather than reserving bortezomib for salvage therapy and using conventional first-line treatment.”

Related Items
Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
Yvette Florio Lane
Web Exclusives published on October 22, 2019 in Breast Cancer, FDA Approvals, In the News, Multiple Myeloma, Pediatric Cancer
FDA Approves Darzalex Combination for First-Line Treatment of Transplant-Eligible Patients with Multiple Myeloma
Web Exclusives published on September 27, 2019 in FDA Approvals, Multiple Myeloma, In the News
Elotuzumab, Lenalidomide, and Dexamethasone Combination Demonstrates High Response Rate in High-Risk Smoldering Multiple Myeloma
Chase Doyle
January/February 2019, Vol 12, Special Issue: Payers’ Perspectives in Oncology: ASH 2018 Highlights published on February 27, 2019 in Multiple Myeloma
Pomalidomide Added to the Regimen in First Relapse Extends PFS in Multiple Myeloma
Wayne Kuznar
August 2018 Vol 11, Special Issue published on August 20, 2018 in Multiple Myeloma
ASCO 2017: Multiple Myeloma Highlights
August 2017, Vol 10, Special Issue: Payers’ Perspectives in Oncology: ASCO 2017 Highlights published on August 24, 2017 in Multiple Myeloma
Last modified: March 16, 2012
  •  Association for Value-Based Cancer Care
  • Oncology Practice Management
  • Value-Based Cancer Care
  • Value-Based Care in Rheumatology
  • Rheumatology Practice Management
  • Urology Practice Management
  • Lynx CME