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Ann Oncol: Efficacy of nivolumab in unidentified primary tumors

 Last Update: 2022-03-04
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Tumors of unknown primary (CUP) have a poor prognosis and limited treatment options
.

Based on the current efficacy of PD-1 inhibitors in tumor treatment, a team from Japan conducted a multi-center, open-label phase II clinical study to evaluate the efficacy and safety of nivolumab (nivolumab) in patients with CUP

Tumors of unknown primary (CUP) have a poor prognosis and limited treatment options

The study included patients with CUP who had received at least one prior systemic chemotherapy
.

Patients with previously untreated CUP were also included in the exploratory analysis

The study included patients with CUP who had received at least one prior systemic chemotherapy

From February 19, 2018, to August 9, 2019, 56 patients with CUP were included, including 45 previously treated and 11 previously untreated patients

Among 45 treatment-experienced patients, 2 (4.

Among 45 treatment-experienced patients, median progression-free survival (PFS) was 4.
0 months (95% CI, 1.
9-5.
8 months), 6-month PFS rate was 32%; median OS was 15.
9 months (95% CI, 8.
4-21.
5 months), the 6-month OS rate was 73%
.

Among 11 previously untreated patients, median progression-free survival was 2.

Among 45 treatment-experienced patients, median progression-free survival (PFS) was 4.

In subgroup analysis, there were no significant differences in PFS and OS of treatment when patients were classified as high-responder or low-responder
.

In subgroup analysis, there were no significant differences in PFS and OS of treatment when patients were classified as high-responder or low-responder

Median PFS was 2.
7 months (95% CI, 1.
4-4.
3) for patients with PD-L1 TPS <1% and 5.
3 months (95% CI, 1.
9-7.
1) for patients with PD-L1 TPS ≥1% (HR , 0.
71 (95% CI, 0.
38-1.
31)); while the median OS was 15.
1 months (95% CI, 7.
8-NR) and 20.
4 months (95% CI, 7.
1-21.
5) (HR, 0.
75 (95 % CI, 0.
32-1.
80))
.

Median PFS was 2.

TMB

TMB TMB

Among all patients, 53 patients (94.
6%) experienced AEs of any grade and 34 patients (60.
7%) experienced grade 3 or 4 AEs
.

Serious AEs occurred in 27 (48.
2%) patients, and 4 (7.
1%) patients discontinued treatment due to AEs
.
No treatment-related deaths occurred
.
The most common adverse reactions (ae) of any grade were constipation (n=13, 23.
2%), anemia (n=10, 17.
9%), diarrhea (n=10, 17.
9%), hypothyroidism (n=9, 16.
1 %) and rash (n=9, 16.
1%)
.
Immune -related AEs or infusion reactions occurred in 32 of 56 patients (57.
1%) , mostly grade 1 or 2
.
Grade 3 or 4 immune-related AEs occurred in 4 (7.
1%) patients, including 2 acute kidney injury and 1 hepatitis and rash
.

Among all patients, 53 patients (94.
6%) experienced AEs of any grade and 34 patients (60.
7%) experienced grade 3 or 4 AEs
.
Serious AEs occurred in 27 (48.
2%) patients, and 4 (7.
1%) patients discontinued treatment due to AEs
.
No treatment-related deaths occurred
.
The most common adverse reactions (ae) of any grade were constipation (n=13, 23.
2%), anemia (n=10, 17.
9%), diarrhea (n=10, 17.
9%), hypothyroidism (n=9, 16.
1 %) and rash (n=9, 16.
1%)
.
Immune -related AEs or infusion reactions occurred in 32 of 56 patients (57.
1%) , mostly grade 1 or 2
.
Grade 3 or 4 immune-related AEs occurred in 4 (7.
1%) patients, including 2 acute kidney injury and 1 hepatitis and rash
.
immunity

In conclusion, this study confirmed the clinical efficacy of nivolumab (nivolumab) in the treatment of tumors of unknown primary (CUP), indicating that it is a promising treatment option
.

In conclusion, this study confirmed the clinical efficacy of nivolumab (nivolumab) in the treatment of tumors of unknown primary (CUP), indicating that it is a promising treatment option
.
This study confirmed the clinical efficacy of nivolumab (nivolumab) in the treatment of tumors of unknown primary (CUP), indicating that it is a promising treatment option
.
This study confirmed the clinical efficacy of nivolumab (nivolumab) in the treatment of tumors of unknown primary (CUP), indicating that it is a promising treatment option
.

Original source:

Tanizaki J, Yonemori K, Akiyoshi K, Minami H, Ueda H, Takiguchi Y, Miura Y, Segawa Y, Takahashi S, Iwamoto Y, Kidera Y, Fukuoka K, Ito A, Chiba Y, Sakai K, Nishio K, Nakagawa K , Hayashi H.
Open-label phase II study of the efficacy of nivolumab for cancer of unknown primary.
Ann Oncol.
2022 Feb;33(2):216-226.
doi: 10.
1016/j.
annonc.
2021.
11.
009.
Epub 2021 Nov 26.
PMID: 34843940.

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