Abstract | OBJECTIVES: With the introduction of novel immune therapeutics for the treatment of disseminated malignancies, we sought to evaluate whether deliberate sequencing of immunotherapy before/after conventional cytotoxic chemotherapy would have an impact on clinical outcomes in patients with previously treated metastatic melanoma. We sought to evaluate whether or not ipilimumab immunotherapy administered before or after cytotoxic chemotherapy (nab-paclitaxel+bevacizumab, AB) would impact clinical outcomes. METHODS: We conducted a randomized phase 2 clinical trial of patients with BRAF wild-type metastatic melanoma (up to 2 prior therapies) who received either: (A) AB followed by ipilimumab therapy at progression; or (B) ipilimumab followed by AB treatment at progression. The primary goal of the study was a comparison of AB versus ipilimumab progression-free survival, with secondary clinical and laboratory endpoints. RESULTS: This study did not reach full accrual due to concurrent Food and Drug Administration approval of anti-programmed cell death 1 agents. Nevertheless, the available data suggests a cumulative therapeutic advantage to the sequential use of ipilimumab followed by AB. Correlative laboratory data revealed a favorable effect on systemic immune homeostasis in patients receiving AB therapy, of potential interest in further investigations, especially in the context of chemotherapy/ immunotherapy combinations. CONCLUSION:
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Authors | Svetomir N Markovic, Vera J Suman, Asad Javed, Joel M Reid, Darci J Wall, Lori A Erickson, Marc Ernstoff, Daniel M Anderson |
Journal | American journal of clinical oncology
(Am J Clin Oncol)
Vol. 43
Issue 2
Pg. 115-121
(02 2020)
ISSN: 1537-453X [Electronic] United States |
PMID | 31809326
(Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
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Chemical References |
- 130-nm albumin-bound paclitaxel
- Albumins
- Antineoplastic Agents, Immunological
- Ipilimumab
- Bevacizumab
- BRAF protein, human
- Proto-Oncogene Proteins B-raf
- Paclitaxel
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Albumins
(administration & dosage)
- Antineoplastic Agents, Immunological
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(administration & dosage)
- Bevacizumab
(administration & dosage)
- Bone Neoplasms
(drug therapy, genetics, secondary)
- Drug Administration Schedule
- Eye Neoplasms
(pathology)
- Female
- Humans
- Ipilimumab
(administration & dosage)
- Liver Neoplasms
(drug therapy, genetics, secondary)
- Lung Neoplasms
(drug therapy, genetics, secondary)
- Male
- Melanoma
(drug therapy, genetics, secondary)
- Middle Aged
- Paclitaxel
(administration & dosage)
- Progression-Free Survival
- Proto-Oncogene Proteins B-raf
(genetics)
- Skin Neoplasms
(pathology)
- Time Factors
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