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Utility of ¹⁸fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma.

Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B - Ann. Oncol. (2015)

Bottom Line: The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology.Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007).When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923).

View Article: PubMed Central - PubMed

Affiliation: Lymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA horwitzs@mskcc.org.

No MeSH data available.


Related in: MedlinePlus

Duration of response [overall independent review committee (IRC)] stratified by (A) radiology response criteria or (B) PET-status for patients with baseline 18fluoro-deoxyglucose positron emission tomography (FDG-PET) assessment. (A) One patient with best response of partial response by overall IRC and progressive disease by radiology response criteria was excluded from this analysis. (B) Two patients with missing response assessment by FDG-PET were excluded from this analysis. CR/CRu, confirmed/unconfirmed complete response; FDG-PET, 18fluoro-deoxyglucose positron emission tomography; IRC, independent review committee; NR, not reached; PD, progressive disease; PR, partial response.
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MDV010F1: Duration of response [overall independent review committee (IRC)] stratified by (A) radiology response criteria or (B) PET-status for patients with baseline 18fluoro-deoxyglucose positron emission tomography (FDG-PET) assessment. (A) One patient with best response of partial response by overall IRC and progressive disease by radiology response criteria was excluded from this analysis. (B) Two patients with missing response assessment by FDG-PET were excluded from this analysis. CR/CRu, confirmed/unconfirmed complete response; FDG-PET, 18fluoro-deoxyglucose positron emission tomography; IRC, independent review committee; NR, not reached; PD, progressive disease; PR, partial response.

Mentions: By overall IRC (n = 110; median follow-up, 22.6 months), the median DOR (n = 33) was 28 months (range, <1–48+ months); the patient whose response was noted as <1 month discontinued to receive an SCT. Other reasons for early discontinuation (DOR <12 months at the time of censoring) included PD (n = 11), patient decision (n = 4), adverse event (n = 3), physician decision (n = 2), and SCT (n = 2). For responding patients, DOR were well differentiated by both conventional radiology response criteria (CR/CRu versus PR; P = 0.0001) and PET status (negative versus positive; P < 0.0001; Figure 1). Of those who became PET-negative during the study, 11 first did so at cycle 2, two patients at cycle 4, 5 patients at cycle 6, and 1 patient at cycle 8. Patients who achieved early PET-negative status (cycle 2) had prolonged DOR compared with those who remained PET-positive at cycle 2, but this difference was not statistically significant (P = 0.1155). For patients who achieved PET-negative status, only one progressed within 12 months of achieving response. Other reasons for early discontinuation included adverse event (n = 1), patient decision (n = 2), SCT (n = 2), and physician decision (n = 1).Figure 1.


Utility of ¹⁸fluoro-deoxyglucose positron emission tomography for prognosis and response assessments in a phase 2 study of romidepsin in patients with relapsed or refractory peripheral T-cell lymphoma.

Horwitz S, Coiffier B, Foss F, Prince HM, Sokol L, Greenwood M, Caballero D, Morschhauser F, Pinter-Brown L, Iyer SP, Shustov A, Nichols J, Balser J, Balser B, Pro B - Ann. Oncol. (2015)

Duration of response [overall independent review committee (IRC)] stratified by (A) radiology response criteria or (B) PET-status for patients with baseline 18fluoro-deoxyglucose positron emission tomography (FDG-PET) assessment. (A) One patient with best response of partial response by overall IRC and progressive disease by radiology response criteria was excluded from this analysis. (B) Two patients with missing response assessment by FDG-PET were excluded from this analysis. CR/CRu, confirmed/unconfirmed complete response; FDG-PET, 18fluoro-deoxyglucose positron emission tomography; IRC, independent review committee; NR, not reached; PD, progressive disease; PR, partial response.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4374388&req=5

MDV010F1: Duration of response [overall independent review committee (IRC)] stratified by (A) radiology response criteria or (B) PET-status for patients with baseline 18fluoro-deoxyglucose positron emission tomography (FDG-PET) assessment. (A) One patient with best response of partial response by overall IRC and progressive disease by radiology response criteria was excluded from this analysis. (B) Two patients with missing response assessment by FDG-PET were excluded from this analysis. CR/CRu, confirmed/unconfirmed complete response; FDG-PET, 18fluoro-deoxyglucose positron emission tomography; IRC, independent review committee; NR, not reached; PD, progressive disease; PR, partial response.
Mentions: By overall IRC (n = 110; median follow-up, 22.6 months), the median DOR (n = 33) was 28 months (range, <1–48+ months); the patient whose response was noted as <1 month discontinued to receive an SCT. Other reasons for early discontinuation (DOR <12 months at the time of censoring) included PD (n = 11), patient decision (n = 4), adverse event (n = 3), physician decision (n = 2), and SCT (n = 2). For responding patients, DOR were well differentiated by both conventional radiology response criteria (CR/CRu versus PR; P = 0.0001) and PET status (negative versus positive; P < 0.0001; Figure 1). Of those who became PET-negative during the study, 11 first did so at cycle 2, two patients at cycle 4, 5 patients at cycle 6, and 1 patient at cycle 8. Patients who achieved early PET-negative status (cycle 2) had prolonged DOR compared with those who remained PET-positive at cycle 2, but this difference was not statistically significant (P = 0.1155). For patients who achieved PET-negative status, only one progressed within 12 months of achieving response. Other reasons for early discontinuation included adverse event (n = 1), patient decision (n = 2), SCT (n = 2), and physician decision (n = 1).Figure 1.

Bottom Line: The use of IWC + PET criteria increased the objective response rate to 30% compared with 26% by conventional radiology.Patients who achieved CR/CRu had prolonged progression-free survival (PFS, median 25.9 months) compared with other response groups (P = 0.0007).When grouping PR and SD patients by PET status, patients with PET-negative versus PET-positive disease had a median PFS of 18.2 versus 7.1 months (P = 0.0923).

View Article: PubMed Central - PubMed

Affiliation: Lymphoma Division, Memorial Sloan-Kettering Cancer Center, New York, USA horwitzs@mskcc.org.

No MeSH data available.


Related in: MedlinePlus