Sintilizumab was approved by NMPA for new indications; The Lancet revealed that lenvatinib as the first-line treatment of advanced hepatocellular carcinoma significantly delayed the deterioration of function;

*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add the editor WeChat yxj_oncology to obtain) Key points: The Lancet: lenvatinib in the first-line treatment of advanced hepatocellular carcinoma is more effective than sorafenib in delaying the deterioration of the function.
Neuro-Oncology: Phase III clinical study reveals that erlotinib combined with whole brain radiotherapy for patients with NSCLC brain metastases does not benefit from iPFS.
New drug: Sintilizumab is approved by NMPA.
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01 The Lancet: Lunvatinib is more effective than sorafenib in the first-line treatment of advanced hepatocellular carcinoma in delaying functional deterioration.
REFLECT published by The Lancet on June 1, 2021 The results of the study showed that compared with sorafenib, lenvatinib's health-related quality of life (HRQOL) benefit evidence supports the use of lenvatinib to delay the deterioration of advanced hepatocellular carcinoma.

Hepatocellular carcinoma is the third leading cause of cancer-related death worldwide.

Maintaining HRQOL during treatment is an important treatment goal.

The purpose of this study was to evaluate the effects of lenvatinib and sorafenib on HRQOL.

Literature release screenshot REFLECT study is a multi-center, phase III, randomized, open-label non-inferiority study, comparing the effectiveness and effectiveness of lenvatinib and sorafenib as first-line systemic treatments for unresectable hepatocellular carcinoma safety.

Between March 14, 2013 and July 30, 2015, 954 eligible patients were randomly selected to receive lenvatinib (n=478) or sorafenib (n=476) at a 1:1 ratio.
Among them, 931 patients can be analyzed [lenvatinib (n=468); sorafenib (n=463)].

 Compared with the full HRQOL, the baseline patient report results (PROs) score reflects impaired HRQOL and function and a considerable burden of symptoms.

 In most PRO scales, the difference between the overall average change and the baseline estimate is usually in favor of lenvatinib rather than the sorafenib group, although this difference is not statistically or clinically significant.

Compared with sorafenib-treated patients, lenvatinib-treated patients experienced QLQ-C30 fatigue (HR 0.
83, 95%CI 0.
69-0.
99), pain (HR 0.
80, 95%CI 0.
66-0.
96) and diarrhea ( HR 0.
52, 95%CI 0.
42-0.
65) there was a statistically significant delay in the deterioration.

02JNCI: Primary tumor lateral shift has certain value in the prognosis and prediction of untreated advanced colorectal cancer.
On June 1, 2021, a meta-analysis published in JNCI showed: Primary tumor lateral shift (PTS) The prognostic value is limited to the KRAS mutant wild-type (KRAS-WT) population.

PTS can predict the efficacy of EGFR inhibitors and significantly improve the overall survival (OS) of patients with left metastatic colorectal cancer (mCRC).

These results suggest that mCRC should be treated based on PTS and KRAS status.

 Screenshots released in the literature.
The study collected and analyzed the PTS data of 9277 mCRC patients from 12 first-line randomized trials in the ARCAD database.
The Kaplan-Meier and Cox models were used to evaluate OS and progression-free survival (PFS).
The performance status, previous radiotherapy/chemotherapy and other factors were adjusted, and the treatment was stratified.

 The results showed that the median OS (21.
6 v 15.
9 months) and median PFS (8.
6 v 7.
5) of the left mCRC patients (n=6856, 73.
9%) compared with the right mCRC patients (n=2421, 26.
1%) Months) longer.

The interaction between PTS and KRAS mutations was statistically significant (p<0.
001): left mCRC in KRAS-WT patients was associated with a better prognosis (OS HRadj = 0.
59, 95%CI = 0.
53-0.
66; PFS HRadj =0.
68, 95%CI = 0.
61-0.
75), but not in patients with KRAS mutations.

In the left KRAS-WT tumor, EGFR inhibitors were beneficial to survival (OS HRadj = 0.
85, 95% CI = 0.
75-0.
97, P = 0.
01; PFS HRadj = 0.
77, 95% CI 0.
67-0.
88, P <0.
001).

03Neuro-Oncology: Phase III clinical study revealed that erlotinib combined with whole brain radiotherapy in patients with NSCLC brain metastases did not benefit from iPFS.
Erlotinib combined with whole brain radiotherapy (WBRT) in patients with non-small cell lung cancer (NSCLC) brain metastases The phase II single-arm trial showed a good objective response rate.

The results of a clinical study published in Neuro-Oncology showed that patients with intention-to-treat (ITT) or patients with EGFR mutations receiving erlotinib combined with whole brain radiotherapy (WBRT) treatment did not improve intracranial progression-free survival compared with WBRT alone.
Phase (iPFS) and no excessive cognitive function (CF) impairment exists.
The results of the study show that although there is no safety problem in taking the drug, there is still no need to use EGFR-TKI combined with WBRT to treat patients with brain metastases.

 Screenshots released in the literature.
The study included NSCLC patients with two or more brain metastases and randomly (1:1) divided into WBRT group (n = 115) and WBRT combined with erlotinib group (n = 109).

The primary end point was the evaluation of iPFS and CF through the Mini Mental State Examination (MMSE).

224 patients from 10 centers in China were randomly assigned to two groups.

The median follow-up was 11.
2 months.

The median iPFS of WBRT combined with erlotinib was 11.
2 months, while the median iPFS of WBRT alone was 9.
2 months (P = 0.
601).

The median free survival (PFS) and overall survival (OS) of the combination group compared with the WBRT group alone were 5.
3 vs 4.
0 months (P = 0.
825) and 12.
9 vs 10.
0 months (P = 0.
545), respectively.

In patients with EGFR mutations, iPFS (14.
6 vs 12.
8 months; P=0.
164), PFS (8.
8 vs 6.
4 months; P=0.
702), OS (17.
5 vs 16.
9 months; P=0.
221), compared with WBRT alone , There was no significant improvement in the combined group.

In addition, there was no significant difference in MMSE scores between the two groups.

04 New drug: Sintilimab was approved by NMPA for new indications.
On June 3, Innovent announced that its PD-1 inhibitor Sintilimab injection was formally approved by China National Medical Products Administration (NMPA) for its new indication.
Approval of the indication application (sNDA), combined with gemcitabine and platinum-based chemotherapy, is suitable for the first-line treatment of inoperable locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

This is Sintilimab injection following NMPA approval in December 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma, and NMPA approval in February 2021 in combination with pemetrexed and platinum The third indication approved after the first-line treatment of advanced non-squamous NSCLC.

According to the announcement, this is also the world's first approved immune-combined gemcitabine and platinum-based chemotherapy regimen for the first-line treatment of squamous NSCLC.

The approval of this indication is based on the results of a randomized, double-blind, phase III controlled clinical (ORIENT-12) study-Sintilimab injection or placebo combined with injection gemcitabine and platinum-based chemotherapy for first-line Treatment of advanced or metastatic squamous NSCLC.

 The ORIENT-12 study showed that Sintilizumab injection combined with gemcitabine for injection and platinum-based chemotherapy for first-line treatment of advanced or metastatic squamous NSCLC significantly prolonged PFS; OS data is not yet mature, but the combination of Sintilizumab There was a trend of benefit in overall survival in the chemotherapy group (HR=0.
567, 95%CI 0.
353-0.
909, P=0.
01701).

The median PFS assessed by the Independent Imaging Committee (IRRC) was 5.
5 months and 4.
9 months, respectively (HR 0.
536, 95%CI 0.
422-0.
681, P<0.
00001), and the median PFS assessed by the investigator was 6.
7 months and 4.
9 months, respectively.
4.
9 months (HR 0.
532, 95%CI 0.
419-0.
674, P<0.
00001), reached the preset primary research endpoint.

The safety characteristics are consistent with the previously reported results of daboshu (sintilimab injection), and there is no new safety signal.

References[1].
Prof Arndt Vogel, Prof Shukui Qin,et al.
Lenvatinib versus sorafenib for first-line treatment of unresectable hepatocellular carcinoma: patient-reported outcomes from a randomised, pen-label, non-inferiority, phase 3 trial.
Published:June 01,2021.
DOI:https://doi.
org/10.
1016/S2468-1253（21)00110-2[2].
Jun Yin, Romain Cohen, Zhaohui Jin, Heshan Liu, et al.
Prognostic and Predictive Impact of Primary Tumor Sidedness for Previously Untreated Advanced Colorectal Cancer, JNCI: Journal of the National Cancer Institute, 2021;, djab112, https://doi.
org/10.
1093/jnci/djab112[3].
Zhenzhou Yang, Yan Zhang, Rongqing Li, Abulimiti Yisikandaer,et al.
Whole-brain radiotherapy with and without concurrent erlotinib in NSCLC with brain metastases: a multicenter, open-label, randomized, controlled phase III trial, Neuro-Oncology, Volume 23, Issue 6, June 2021,Pages 967–978, https://doi.
org/10.
1093/neuonc/noaa281[4].
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