Correspondence

Atezolizumab in Advanced Squamous Cell Carcinoma of

the Penis
TO THE EDITOR: repeated every 21 days for at least two cycles. Their results
showed that the PRaG regimen was well tolerated and
In their phase II PERICLES trial, de Vries et al1 investigated
represented a promising salvage treatment for these pa-
the efficacy and toxicity of atezolizumab with or without
tients. What we suggest is that it is not accurate to de-
radiotherapy (RT) in advanced squamous cell carcinoma of
termine which patients may benefit from PD-(L)1
the penis, and they found that the 1-year progression-free
inhibitor and RT on the basis of the metastasis status of
survival (PFS) was 12.5% (95% CI, 5.0 to 31.3) in the complete
patients, and the optimum RT strategy for metastatic
study cohort, which did not meet the study’s primary end
patients remains elusive.
point. The median overall survival was 11.3 months (95% CI,
5.5 to 18.7 months) in the complete study cohort and was
similar in arm A (atezolizumab plus RT) versus arm B Finally, we congratulate de Vries et al1 on their valuable study
(atezolizumab alone). Improved PFS was observed in pa- to provide treatment guidance and presented biomarkers to
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tients with high-risk human papillomavirus–positive tu- predict outcomes for patients with advanced penile squa-
mors (P 5 .003) and those with high infiltration of mous cell carcinoma treated with atezolizumab, and their
Copyright © 2024 American Society of Clinical Oncology. All rights reserved.

intratumoral CD31CD81 T cells (P 5 .037). Despite impressive
results, we have a concern about this trial.
According to the study protocol, patients who were not
expected to derive benefit from radiotherapeutic treatment
(eg, in case of distant metastasis) were treated with ate-
zolizumab alone. However, in the atezolizumab plus RT
group, besides the locally advanced patients, there was a
great proportion (60%) of patients with metastatic dis-
eases (Table 1). Our confusion is that, how shall we de-
termine in advance which patients might benefit from
irradiation and which patients might not before conducting
this trial. In addition, is a high-dose and large-area irra-
diation of both primary tumor and all affected pelvic and
inguinal lymph node regions necessary for those with
metastatic diseases? A phase II trial by Kong et al2 assessed
the role of RT in combination with PD-1 inhibitor and
granulocyte macrophage colony-stimulating factor (PRaG
regimen) in patients with metastatic solid tumors. They
used a RT strategy of three fractions of 5 or 8 Gy delivered
for one metastatic lesion, and the PRaG regimen was
findings would be very helpful for future research.
Yao-Ning Feng, MD
Urology Surgery Department, The Fifth Affiliated Hospital of
Guangxi Medical University, Nanning, Guangxi, China
The First People’s Hospital of Nanning, Nanning, Guangxi, China
Li Xiao, MD
Department of Critical Care Medicine, The Fifth Affiliated
Hospital of Guangxi Medical University, Nanning, Guangxi,
China
The First People’s Hospital of Nanning, Nanning, Guangxi, China
Guang-Yu Xie, MD
Urology Surgery Department, The Fifth Affiliated Hospital of
Guangxi Medical University, Nanning, Guangxi, China
The First People’s Hospital of Nanning, Nanning, Guangxi, China
AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS
OF INTEREST
Disclosures provided by the authors are available with this article at DOI
https://doi.org/10.1200/JCO.23.01818.

REFERENCES
1. de Vries HM, Rafael TS, Gil-Jimenez A, et al: Atezolizumab with or without radiotherapy for advanced squamous cell carcinoma of the penis (the PERICLES study): A phase II trial. J Clin Oncol 41:
4872-4880, 2023
2. Kong Y, Zhao X, Xu M, et al: PD-1 inhibitor combined with radiotherapy and GM-CSF (PRaG) in patients with metastatic solid tumors: An open-label phase II study. Front Immunol 13:952066, 2022

DOI: https://doi.org/10.1200/JCO.23.01818; Published at ascopubs.org/journal/jco on November 16, 2023.

242 | Volume 42, Issue 2 | ascopubs.org/journal/jco

 Correspondence

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Atezolizumab in Advanced Squamous Cell Carcinoma of the Penis

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