Title: Intensive treatment of triple negative breast cancer with residual positive axillary lymph
node after neoadjuvant chemotherapy
Version: 1 Date: 08 Oct 2024
Reviewer's report:
This single-center, prospective clinical trial randomized 22 high risk patients (disease in the
lymph nodes after neoadjuvant chemotherapy) to receive adjuvant treatment with vinorelbine
or placebo, after receiving standard treatment for triple negative breast cancer. Even though the
study included only a small number of patients, and stopped earlier due to slow progress of
enrollment, it had some impressive results, raising an interesting hypothesis.
Background
Please review this whole paragraph:
"A previous study [6] revealed that the complete remission rate of axillary lymph nodes and 3-
year DDFS rate (91.7% vs. 78.8%, P = 0.016, HR = 2.17) after NAC were statistically better in
patients (BETTER THAN PATIENTS?)
with locally advanced breast cancer with axillary lymph node metastasis. Among patients with
negative hormone receptors and residual lymph node cancer, the 5-year risk of distant metastasis
and death increased by 4.256 fold (95% confidence interval [CI]: 1.14–24.17, P = 0.033) and
6.478 fold (95%CI: 1.58–35.30, P = 0.011), respectively, for those who did not receive NAC
after surgery (?????)
[7], and these results were consistent with the results of the CREATE-X study [8]."
Experimental design
Figure 1 states that 304 patients were randomized. Please make it clear that 22 patients were
actually randomized.
Statistical analyses
How was it possible to maintain the predetermined statisticial analysis plan if the study recruited
22 patients and was planned to recruit 304 patients? Please clarify.
"All statistical analyses were performed according to the predetermined statistical analysis plan,
and the statistical analysis report of the research results was written."
Results
Table 1:
Some acronym are not in the legends (IDC II, IDC III, ILC). The groups seem to be statistically
different, please consider including this analysis in the table.
I couldn´t understand these results below:
"Multivariate analysis showed that the control group had more survival events than the intensive
treatment group. The difference in DDFS (HR= 0.19; 95% CI, 0.02–1.76), RFS (HR= 0.19; 95%
CI, 0.02–1.76), and OS (HR=0.32; 95% CI, 0.03–3.42) between the two groups showed a trend
but without statistical significance (Table 2)."
Table 2 is not weel configured, and thus not understandable.
Since toxicity and safety are important objectives of the study, I suggest a table describing all
the adverse events in the two groups.
Discussions
The discussion basically focuses in the limitations of the study (enrollment, create-X, IV
vinorelbine instead of oral). I suggest you consider discussing the key points of the study first,
because you have some very interesting results (90vs42%, 90vs60%), that could be further
explored in a larger multicenter trial. I suggest you explore how a safe and accessible drug can
change the history of a very agressive breast cancer.
Conclusions
Please reconsider your conclusion. I think it´s not possible to say that vinorelbine is optimal for
TNBC with residual cancer in the lymph nodes based in this study.
"In conclusion, the clinical efficacy and tolerance of adjuvant intensive vinorelbine therapy are
optimal for TNBC patients with residual cancer in the lymph nodes after NAC with anthracycline
followed by paclitaxel."
Please review the writing, there are a few spelling mistakes along the paper (nonadjuvant in the
statistical analysis for example).