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*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 it to the editor's WeChat yxj_oncology to get it) Key points Leukemia: Does receiving ionizing radiation in a young age cause malignant lymphoma? JNCI: Pre-menopausal early breast cancer research needs to consider patients' ovarian function endpoints.
New drug: the first domestic first-line hepatocellular carcinoma targeted drug will be approved soon.
New drug: Sintilizumab.
The third indication is about to be launched.
Indications for adjuvant treatment of icotinib will soon be approved 01Leukemia: Will receiving ionizing radiation at a young age cause malignant lymphoma? There is very limited evidence on the incidence of non-leukemic malignant lymphoma caused by radiation.
Because the risk of cancer associated with radiation exposure in childhood is usually higher, the investigators used active bone marrow (ABM) and lymphatic system dose (if available) to analyze a cohort of 9 lymphoma tumors <21 years of age at the time of first exposure to external radiation Data, and fitted relative and absolute risk models, carried out a unified classification of outcomes.
The study was published in Leukemia, and the results suggest that a significant increase in the risk of borderline disease has been observed in multiple cohorts, but further research is still needed.
Screenshot of the official website At the end of the follow-up (average 42.
1 years), 593 cases of lymphoma were diagnosed among 143,136 people (422 cases of non-Hodgkin (NHL), 107 cases of Hodgkin (HL), 64 cases of indeterminate subtype), 66 cases Chronic lymphocytic leukemia (CLL) and 122 multiple myeloma (MM) deaths and new cases, the average ABM dose was 0.
14 Gy (range 0-5.
95 Gy), and the average age at first exposure was 6.
93 years.
Excess relative risk (ERR) did not increase significantly in the following cohorts: lymphoma (ERR/Gy = -0.
001; 95% CI: -0.
255, 0.
279), HL (ERR/Gy = -0.
113; 95% CI: -0.
669, 0.
709), NHL + CLL (ERR/Gy = 0.
099; 95%CI: -0.
149, 0.
433), NHL (ERR/Gy = 0.
068; 95%CI: -0.
253, 0.
421), CLL (ERR/Gy = 0.
320; 95 %CI: -0.
678, 1.
712) or MM (ERR/Gy = 0.
149; 95%CI: -0.
513, 1.
063), and all p trends are> 0.
4.
In 6 cohorts with estimated lymphoid tissue doses, a significant increase in the critical risk of NHL + CLL, NHL, and CLL was observed (p trend = 0.
02-0.
07).
It is necessary to further summarize the epidemiological studies with longer follow-up time, to conduct a central outcome review by a hematological pathologist, and to evaluate the radiation dose to the lymphatic tissue.
02JNCI: Premenopausal early breast cancer research needs to consider patient ovarian function endpoints.
The Journal of the National Cancer Institute (JNCI) published an online article titled "Phase III (New) Adjuvant Breast Cancer Clinical Trials" on May 28, 2021.
Evaluation of Ovarian Function: A Systematic Review article.
The investigator said: In the trial of stage III breast cancer (neo) adjuvant therapy included in premenopausal women, the effect of drug intervention on ovarian function is rarely evaluated.
Considering its importance for informed decision-making, experimenters should consider including ovarian function endpoints when designing clinical trials.
Screenshot of the official website.
Eligible trials are phase III (new) adjuvant trials of breast cancer drug therapy recruited from June 2008 to October 2019 and included in premenopausal women.
The results showed that among the 2,354 records identified, 141 tests passed.
Research treatments include chemotherapy (36.
9%), HER2 targeted therapy (24.
8%), endocrine therapy (12.
8%), immunotherapy (7.
8%), CDK4/6 inhibitors (5.
0%), and PARP inhibitors (2.
8%).
In 13 trials (9.
2%), ovarian function was the predetermined endpoint.
Forty-five (31.
9%) trials collected data on ovarian function, but only 33 (23.
4%) collected post-trial intervention data.
Common post-intervention data collected include menstruation (15.
6%), pregnancy (13.
5%), estradiol (9.
9%), and follicle-stimulating hormone levels (8.
5%).
Only 4 (2.
8%) trials collected post-intervention anti-mullerian hormone levels, and 3 (2.
1%) trials collected antral follicle counts.
In 22 trials investigating immunotherapy, CDK4/6 inhibitors, or PARP inhibitors, ovarian function was not used as an endpoint, but 4 (18.
2%) collected data on ovarian function after intervention.
03 New drug: The first domestically produced first-line hepatocellular carcinoma targeted drug will soon be approved for marketing.
On May 31, the official website of the National Medical Products Administration (NMPA) showed that Zejing Pharmaceutical's Class 1 new drug, Donafenib Tosylate, was applied for the listing of a new drug It is already in the "under approval" stage and will be approved by the NMPA in the near future for the treatment of advanced (inoperable or metastatic) hepatocellular carcinoma.
Screenshot from the official website 04 New drug: Sintilimab's third indication is about to be launched.
On May 31, the NMPA official website showed that the innovative PD-1 inhibitor Sintilimab injection jointly developed by Innovent and Eli Lilly is used for The new indication application (sNDA) for the first-line treatment of squamous non-small cell lung cancer (NSCLC) is already in the "under review" stage.
It will soon be approved by NMPA for listing.
This will be the third indication for the product to be approved.
Screenshot of the official website 05 new drug: domestic EGFR-TKI icotinib postoperative adjuvant treatment indication will be approved soon.
On May 28, the NMPA official website showed that Betta Pharmaceuticals icotinib tablet new indication listing application (acceptance number: CXHS2000030 ) Is already in the "under approval" stage and will be approved by NMPA for listing in the near future.
For postoperative adjuvant treatment of non-small cell lung cancer (NSCLC) patients with sensitive mutations in the epidermal growth factor receptor (EGFR) gene.
This will be the third indication for the product to be approved.
Official website screenshot reference: [1]Little, MP, Wakeford, R.
, Zablotska, LB et al.
Lymphoma and multiple myeloma in cohorts of persons exposed to ionising radiation at a young age.
Leukemia (2021).
https://doi .
org/10.
1038/s41375-021-01284-4[2]Cui W, Francis PA, Loi S, Hickey M, Stern C, Na L, Partridge AH, Loibl S, Anderson RA, Hutt KJ, Keogh LA, Phillips KA .
Assessment of Ovarian Function in Phase 3 (Neo) adjuvant Breast Cancer Clinical Trials: A Systematic Evaluation.
J Natl Cancer Inst.
2021 May 28:djab111.
doi: 10.
1093/jnci/djab111.
Epub ahead of print.
PMID: 34048575.
[ 3]https://mp.
weixin.
qq.
com/s/EG9jvFGxUmSsg84GKVVVYg[4]https://mp.
weixin.
qq.
com/s/IWgwwoZD8UB_f8WUtJ_Cuw[5]https://mp.
weixin.
qq.
com/ s/W1gGcRtLAc4vGfQQQiDAEA