​​Cytokine storm appeared after cancer patients were vaccinated with the new crown vaccine; the bispecific antibody teclistamab was recognized as a breakthrough therapy.

*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 get it) Key points: Nature Medicine: After a cancer patient was vaccinated with the new crown mRNA vaccine, a cytokine storm appeared.
The Lancet: The sustainability of neutralizing antibodies induced by the bivalent HPV vaccine Higher than quadrivalent vaccine JAMA Oncol: There is no significant difference in the SARS-CoV-2 antibody status between cancer patients and medical staff during the COVID-19 pandemic in Japan.
JCO: Breast cancer risk assessment model for pediatric cancer survivors receiving chest radiotherapy to help new drugs for risk prevention : The bispecific antibody teclistamab targeting BCMA has been approved as a breakthrough therapy for the treatment of R/R MM01 Nature Medicine: A cytokine storm appeared after a cancer patient was vaccinated with the new crown mRNA vaccine May 26, 2021, Nature Medicine published A study found that a patient with colorectal cancer who received PD-1 therapy for a long time experienced a cytokine storm (CRS) after being vaccinated with the mRNA new crown vaccine developed by Pfizer/BioNTech.

 Screenshots released in the literature.
This 58-year-old male patient started receiving monotherapy with anti-PD-1 monoclonal antibody in February 2019 for the treatment of his metastatic mismatch repair defective colorectal cancer.

A case of CRS occurred 5 days after inoculation of BTN162b2 (tocinamylamine)-Pfizer BioNTech mRNA COVID-19 vaccine.

 CRS is manifested by elevated inflammation markers, thrombocytopenia, elevated cytokine levels (IFN-γ/IL-2R/IL-18/IL-16/IL-10) and steroid reactivity.

The close time correlation between vaccination and CRS diagnosis in this case indicates that CRS is a vaccine-related adverse event; PD-1 inhibitors are a potential factor.

 In general, cancer patients need further prospective pharmacodynamic data.

02The Lancet: The sustainability of neutralizing antibodies induced by the bivalent HPV vaccine is higher than that of the quadrivalent vaccine.
On May 31, The Lancet released a joint follow-up analysis of data from two randomized, double-blind, multi-center phase III trials, namely PATRICIA (Bivalent, HPV16 and 18) and FUTURE II (tetravalent, HPV6, 11, 16 and 18), the significant difference in immunogenicity observed between the two vaccines is consistent with the difference in cross-protective efficacy.

The antibody titer induced by the protective HPV vaccine can be detected within 12 years after vaccination.

 The analysis evaluated the concentration of neutralizing antibodies (type-specific seroprevalence) against HPV types 6, 16, and 18 from 2 to 12 years after vaccination, and cross-neutralization of non-vaccine HPV types 31, 33, 45, 52, and 58 Antibody response.

The researchers tracked and analyzed the cohort data from two international, randomized, double-blind, phase III trials of HPV vaccines from Finland, namely PATRICIA and FUTURE II.

In 2002 and 2004-05, 16-17-year-old Finnish girls participated in one of the two trials and agreed to follow-up health registration at the Finnish Cancer Registry.

These cohorts are also linked to the Finnish Maternity Cohort (FMC), which collected almost all Finnish pregnant women's serum samples in the first three months, and obtained 2,046 post-vaccination serum samples during 12-year follow-up.

We obtained serum samples from FMC-based follow-ups in the FUTURE II trial and the PATRICIA trial (the recipients are ranked by follow-up time and matched with the number of pregnancies).

We assessed the concentration of neutralizing antibodies (type-specific seroprevalence) against HPV types 6, 16, and 18 from 2 to 12 years after vaccination, and cross-neutralizing antibodies against non-vaccine HPV types 31, 33, 45, 52, and 58 reaction.

 Screenshots of the publication of the literature As of December 31, 2016, the researchers analyzed 577 serum samples from tetravalent vaccine vaccinators and 568 from bivalent vaccine vaccinators.

The analysis results are as follows: ①In 681 first pregnancy serum samples, neutralizing antibodies to HPV 6, 16, and 18 were generally found 12 years after vaccination.

 ②51 (15%) of the 339 quadrivalent vaccine recipients had no HPV18 neutralizing antibodies detected within 2-12 years after vaccination, while all 342 bivalent vaccine recipients had HPV18 neutralizing antibodies.

 ③ Among the seropositive tetravalent vaccine vaccinators, the geometric mean titre (GMT) of HPV16 in the 5-7 years (GMT 3679, 95% CI 2377-4708) is higher than that in the 2-4 years (GMT 6642, 95% CI 2371).
-13717) reduced by half.

 ④5-12 years after vaccination, the GMT of HPV16 and 18 neutralizing antibodies of seropositive bivalent vaccine vaccinators are 5.
7 times and 12.
4 times that of quadrivalent vaccine vaccinators, respectively.

 ⑤ Cross-neutralizing antibodies against HPV 31, 33, 45, 52 and 58 are more common among bivalent vaccine recipients, but within 12 years after vaccination with similar GMT in the two vaccine cohorts, if it can be measured, it can be sustainable .

 ⑥ The seroprevalence rates of HPV16, 31, 33, 52 and 58 are only significantly related to the efficacy of the bivalent vaccine against persistent HPV infection (rs=0.
90, 95%CI 0.
09-0.
99, P=0.
037, quadrivalent vaccine The vaccinated person's rs=0.
62, 95%CI 0.
58-0.
97, P=0.
27).

Among the tetravalent vaccine vaccinators, the correlation between the protective efficacy and the positive rate of neutralizing or cross-neutralizing HPV antibodies was not significant.

03JAMA Oncol: There is no significant difference in SARS-CoV-2 antibody status between cancer patients and medical staff during the COVID-19 pandemic in Japan.
JAMA Oncology published an article on cancer patients and medical staff during the COVID-19 pandemic in Japan on May 28, 2021.
A baseline investigation of the difference in the antibody status of the new coronavirus (SARS-CoV-2).  Studies have shown that in a cross-sectional study (prevalence survey) of cancer patients and health care workers (HCWs) in Japan, there was no difference in the seropositivity rate of SARS-CoV-2 antibodies between the two groups; however, the results of the study showed that comorbidities Cancer and systemic treatments, including chemotherapy and immune checkpoint inhibitors, may affect the immune response to SARS-CoV-2.

 Screenshots of literature release This prospective cross-sectional study was enrolled from 2 comprehensive cancer centers in endemic areas around Tokyo, Japan from August 3 to October 30, 2020.

Cancer patients and employees over the age of 16 were included in the study.

Participants suspected of being infected with COVID-19 at the time of inclusion were excluded.

 This baseline study mainly detects the seroprevalence and antibody levels of cancer and HCWs patients.

Seropositivity is defined as positive for anti-new coronavirus N protein IgG antibody (N-IgG) and/or anti-S protein IgG antibody (S-IgG).

Chemiluminescence enzyme immunoassay was used to detect serum SARS-CoV-2 IgM and IgG antibody levels.

 Results A total of 500 cancer patients [median age 62.
5 years (range, 21-88 years); 265 men (55.
4%)] and 1190 HCWs [median age, 40 years (range, 20-70 years); 382 (25.
4%) men were recruited.

Among the tumor patients, 489 cases (97.
8%) were solid tumors, and 355 cases (71.
0%) received anti-cancer treatment within one month.

Among HCWs, there are 385 nurses or assistant nurses (32.
3%), 266 administrative staff (22.
4%), 197 researchers (16.
6%), 179 doctors (15.
0%), and 113 technicians (9.
5%).
50 pharmacists (4.
2%).

 The seroprevalence rate of patients was 1.
0% (95% CI 0.
33%-2.
32%), and the seroprevalence rate of HCWs was 0.
67% (95% CI, 0.
29%-1.
32%) (P = 0.
48).  However, the patient’s N-IgG and S-IgG antibody levels were significantly lower than HCWs (N-IgG: β, −0.
38; 95% CI −0.
55~ −0.
21; P<.
001; S-IgG: β −0.
39; 95 % CI −0.
54 ~ −0.
23; P<0.
001).

In addition, among patients, the N-IgG level of patients who received chemotherapy was significantly lower than that of patients who did not receive chemotherapy [median N-IgG level, 0.
1 (interquartile range (IQR), 0-0.
3) vs 0.
1 (IQR, 0-0.
4), P=0.
04] In contrast, the levels of N-IgG and S-IgG in patients treated with immune checkpoint inhibitors were significantly higher than those in patients who did not receive checkpoint inhibitors [N-IgG Median level: 0.
2 (IQR, 0.
1-0.
5) vs 0.
1 (IQR, 0-0.
3), P = .
02; Median level of S-IgG: 0.
15 (IQR, 0-0.
3) and 0.
1 (IQR, 0- 0.
2), P = 0.
02).

04JCO: Breast cancer risk assessment model for pediatric cancer survivors receiving chest radiotherapy helps risk prevention.
Recently, a study published in the Journal of Clinical Oncology showed a study on a breast cancer risk prediction model.

The research sought to develop and validate a breast cancer risk prediction model for childhood cancer survivors who received thoracic radiation therapy, which combined treatment-related factors, family history, and reproductive factors for risk assessment.

Accurate risk prediction helps refine the monitoring and prevention strategies for this population.

 Screenshots released in the literature The analysis is based on a multi-national cohort, diagnosed as a 5-year female cancer survivor younger than 21 years old and receiving thoracic radiation therapy.

 Model derivation is based on 1120 children cancer survivor study participants diagnosed from 1970 to 1986, with an average age of 42 years (20-64 years), and 242 breast cancer patients.

Model validation included 1027 participants from three cohorts, with a median age of 32 years (20-66 years) and 105 patients with breast cancer.

The model included current age, chest radiation field, whether to receive chest radiation within 1 year of menarche, anthracycline exposure, menopausal age, and breast cancer first-degree relative history.

For 30-year-old women, the 10-year risk estimate ranges from 2% to 23% (AUC: 0.
63; 95% CI: 0.
50-0.
73) and from 5% to 34% for 40-year-old women (AUC: 0.
67; 95%) CI: 0.
54-0.
84).

Among premenopausal women over 40 who received mantle field radiation therapy within one year of menarche, their first-degree relatives have the highest risk of breast cancer.

It shows a good calibration, with an expected to observed ratio of the number of breast cancers of 0.
92 (95% CI: 0.
74 to 1.
16).

05New drug: The bispecific antibody teclistamab targeting BCMA has been approved as a breakthrough therapy for the treatment of R/R MM.
Today, the US FDA has granted a breakthrough in the T cell redirecting bispecific antibody teclistamab targeting B cell maturation antigen (BCMA) Sexual therapy is recognized for the treatment of patients with relapsed or refractory multiple myeloma (R/R MM).

Obtaining a breakthrough therapy designation will help speed up the development and regulatory review process of this innovative therapy.

Earlier this year, teclistamab also obtained the Priority Drug Qualification (PRIME) issued by the European Union EMA.

This breakthrough therapy designation is based on data from the phase I clinical trial MajesTEC-1.

In this dose-escalation clinical trial, when the median follow-up time was more than 6 months, the R/R MM patients who received the recommended dose of subcutaneous injection in the phase II clinical trial achieved an overall response rate (ORR) of 65%.

The median number of pre-treatments for these patients was 5.

The results of the study showed that the patient's remission was durable and deepened over time.

58% of patients achieved very good partial remission (VGPR), and 40% of patients achieved complete remission (CR).

At a median follow-up time of 7.
1 months, 85% of remission patients were still receiving treatment. The latest results of this research will be announced at the ASCO annual meeting to be held in the near future.

References: [1]Au, L.
, Fendler, A.
, Shepherd, STC et al.
Cytokine release syndrome in a patient with colorectal cancer after vaccination with BNT162b2.
Nat Med (2021).
https://doi.
org/ 10.
1038/s41591-021-01387-6.
[2]Mariz, Filipe Colaço et al.
Sustainability of neutralising antibodies induced by bivalent or quadrivalent HPV vaccines and correlation with efficacy: a combined follow-up analysis of data from two randomised, double- blind, multicentre, phase 3 trials.
The Lancet Published:May 31, 2021.
doi:https://doi.
org/10.
1016/S1473-3099(20)30873-2[3]Yazaki S, Yoshida T, Kojima Y, et al.
Difference in SARS-CoV-2 Antibody Status Between Patients With Cancer and Health Care Workers During the COVID-19 Pandemic in Japan.
JAMA Oncol.
Published online May 28, 2021.
doi:10.
1001/jamaoncol.
2021.
2159[4]Chaya S.
Moskowitz, et al.
Development and Validation of a Breast Cancer Risk Prediction Model for Childhood Cancer Survivors Treated With Chest Radiation: A Report From the Childhood Cancer Survivor Study and the Dutch Hodgkin Late Effects and LATER Cohorts.
10.
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02244 Journal of Clinical Oncology[5]https ://mp.
weixin.
qq.
com/s/M7u2EooCrYV4Vp_JspcgOw