scholarly journals Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III–IV melanoma

Author(s):  
Robert H. I. Andtbacka ◽  
Frances Collichio ◽  
Kevin J. Harrington ◽  
Mark R. Middleton ◽  
Gerald Downey ◽  
...  
1998 ◽  
Vol 16 (9) ◽  
pp. 2930-2936 ◽  
Author(s):  
A Ravaud ◽  
C Chevreau ◽  
L Cany ◽  
P Houyau ◽  
N Dohollou ◽  
...  

PURPOSE A randomized unblinded phase III trial was designed to determine the ability of granulocyte-macrophage colony-stimulating factor (GM-CSF) to accelerate recovery from febrile neutropenia induced by chemotherapy. PATIENTS AND METHODS A total of 68 patients with febrile neutropenia following chemotherapy defined as axillary temperature greater than 38 degrees C and absolute neutrophil count (ANC) less than 1 x 10(9)/L were included. After stratification for high- and low-risk chemotherapy to induce febrile neutropenia, treatment was randomized between GM-CSF at 5 microg/kg/d or control, both being associated with antibiotics. RESULTS GM-CSF significantly reduced the median duration of neutropenia from 6 to 3 days for ANC less than 1 x 10(9)/L(P < .001) and from 4 to 3 days for ANC less than 0.5 x 10(9)/L (P=.024), days of hospitalization required for febrile neutropenia, and duration of antibiotics during hospitalization. The greatest benefit with GM-CSF appeared for patients who had received low-risk chemotherapy, for which the median duration of ANC less than 1 x 10(9)/L was reduced from 7 to 2.5 days (P < .001) and from 4 to 2 days for ANC less than 0.5 x 10(9)/L (P=.0011), the duration of hospitalization during the study from 7 to 4 days (P=.003), and the duration on antibiotics during hospitalization from 7 to 3.5 days (P < .001). A multivariate analysis, using Cox regression, showed that variables predictive for recovery from neutropenia were GM-CSF (P=.0010) and time interval between the first day of chemotherapy and randomization (P=.030). There was no benefit for GM-CSF when high-risk chemotherapy was considered. CONCLUSION GM-CSF significantly shortened duration of neutropenia, duration of neutropenic fever-related hospitalization, and duration on antibiotics during hospitalization when febrile neutropenia occurred after low-risk chemotherapy, but not high-risk chemotherapy.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. LBA9008-LBA9008 ◽  
Author(s):  
Robert Hans Ingemar Andtbacka ◽  
Frances A. Collichio ◽  
Thomas Amatruda ◽  
Neil N. Senzer ◽  
Jason Chesney ◽  
...  

LBA9008 The full, final text of this abstract will be available at abstract.asco.org at 7:30 AM (EDT) on Saturday, June, 1, 2013, and in the Annual Meeting Proceedings online supplement to the June 20, 2013, issue of Journal of Clinical Oncology. Onsite at the Meeting, this abstract will be printed in the Saturday edition of ASCO Daily News.


2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A628-A628
Author(s):  
Song Park ◽  
Ata Moshiri ◽  
Rouba Hadi ◽  
Austin Green ◽  
Jennifer Gardner ◽  
...  

BackgroundTalimogene laherparepvec (T-VEC) has become an increasingly popular treatment option for surgically non-resectable, recurrent melanoma based on its durable efficacy and safety profile. The complete response (CR) rate has been reported to be ~20% with a median of ~9 months to achieve it. [figure 1,2] Assessment of treatment response in those studies has predominantly relied on the clinical impression of the size and color of the lesions. However, in the real-world, decrease of tumor size often occurs rapidly within the first 2–3 months, while improvement of the pigmentation takes several more months. Such clinical observation of lasting pigmentation could be explained by tumoral melanosis – a histopathologic term referring to the presence of a melanophage-rich inflammatory infiltrate without remaining viable tumor cells.MethodsWe hypothesized that residual pigmentation of stable melanoma lesions while on successful T-VEC treatment may represent tumoral melanosis. We also report practical information of such phenomenon including timeline and clinical features.ResultsWe report 6 cases of metastatic cutaneous melanoma treated with T-VEC with excellent pathologic responses. Biopsies of 5 cases were performed after observing variable clinical changes in the injected tumors, with some shrinking or becoming flat, while others grew or became raised. The range of time to biopsy was 4–23 months from the initial treatment date. Pathologic evaluation macular lesions demonstrated non-viable tumor tissue with tumoral melanosis in all cases. In an additional case, clinically increased size of the injected tumor prompted surgical excision, which similarly showed tumoral melanosis without viable tumor. Of note, while size of the tumor was increased, SUV max of the lesion decreased from prior assessment on PET-CT. No patient has developed regrowth or recurrent melanoma of the injected lesions to date (figure 1).Abstract 593 Figure 1Summary of patient characteristicsConclusionsIn patients receiving T-VEC treatment, pathologic CR may be achieved within the first 2–3 months, which precedes clinical improvement of pigmentation. To decrease unnecessary additional T-VEC treatment and assess the response correctly, serial biopsy of stable pigmented lesions should be considered to assess for the presence or absence of viable tumor.AcknowledgementsN/ATrial RegistrationN/AEthics ApprovalIRB exempted for case report with no patient-identifiable informationConsentN/AReferencesHarrington KJ, Andtbacka RH, Collichio F, et al. Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the Phase III OPTiM trial. Onco Targets Ther 2016;9:7081–7093.Andtbacka RHI, Collichio F, Harrington KJ, et al. Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III–IV melanoma.


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