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*Only for medical professionals to read and reference for 1 minute a day, to give you professional "talks" in the tumor circle! (If you need the original text, you can add the editor's WeChat yxj_oncology to get it) Key tips THE LANCET ONCOLOGY: Ibrutinib-rituximab induction may reduce chemotherapy cycles in young (≤65 years old) patients with mantle cell lymphoma JCO: Children and juvenile thyroid cancer radioactive iodine therapy is associated with increased risk of several solid tumors Channel Eligibility 01THE LANCET ONCOLOGY: Ibrutinib-rituximab induction may reduce chemotherapy cycles in young (≤65 years) patients with mantle cell lymphoma Continued rituximab plus high fractionation cyclophosphamide, vincristine, doxorubicin, and dexamethasone (R-HCVAD) alternating with methotrexate-cytarabine shortens chemistry in patients with untreated mantle cell lymphoma The immunotherapy cycle study, published in THE LANCET ONCOLOGY, showed that ibrutinib-rituximab induction is effective and safe for first-line treatment of young patients with mantle cell lymphoma
.
Screenshot of the official website The researchers conducted a single-center, single-arm, phase II trial in patients with untreated mantle cell lymphoma
.
Eligible patients were aged 65 years and younger, serum bilirubin ≤1.
5 mg/dL, creatinine clearance ≤30 mL/min, Eastern Cooperative Oncology Group functional status score ≤2, echocardiographic cardiac ejection fraction ≥50%
.
Patients received 12 cycles of ibrutinib-rituximab induction (Part A; ibrutinib 560 mg orally daily and rituximab 375 mg/m2 weekly intravenously, weekly for the first 4 weeks , followed by Day 1 of Cycles 3-12)
.
Once the patient is in complete remission, four cycles of R-HCVAD alternating with methotrexate-cytarabine (Part B) are administered immediately
.
If patients did not have a complete response or had a partial response, they received two cycles of R-HCVAD alternating with methotrexate-cytarabine and then reassessed for a total of eight cycles
.
Patients were withdrawn from the study if their disease was stable or progressed while receiving R-HCVAD
.
The primary outcome showed the overall response rate after Part
A.
Results showed that 131 patients were enrolled between June 12, 2015, and December 6, 2018
.
Fifty-eight (50%) of 117 patients had high Ki-67 levels (≥30%)
.
129 of 131 patients (98%, 95% CI: 95-100) had a response in Part
A.
The most common grade 3-4 adverse events were lymphopenia (14%), rash (12%), thrombocytopenia (9%), infection (8%), and fatigue (8%) in part A and fatigue (8%) in part B.
Lymphopenia (73%), leukopenia (32%), thrombocytopenia (30%) and neutropenia (20%)
.
There was one death in the study, but it was not considered treatment-related
.
The results suggest that ibrutinib-rituximab induction is effective and safe for first-line treatment of young patients with mantle cell lymphoma
.
This approach minimizes the number of chemotherapy cycles and thus reduces chemotherapy-related adverse events
.
Introducing a Next-Generation Bruton's Tyrosine Kinase (BTK) Inhibitor to Frontline Therapy in New Clinical Trial May Completely Avoid the Need for Chemotherapy in Mantle Cell Lymphoma Patients
.
02JCO: Radioactive iodine therapy for thyroid cancer in children and adolescents is associated with increased risk of several solid tumors Since the 1980s, both the incidence of differentiated thyroid cancer (DTC) and the use of radioactive iodine (RAI) therapy have increased significantly
.
RAI has been shown to be associated with an increased risk of leukemia, but the risk of second solid malignancies is unknown, and children are more susceptible to the late effects of radiation than the elderly in older adults
.
Recently, a study investigating the risk of second primary malignancy in children and young adults associated with RAI treatment of DTC was published in the Journal of Clinical Oncology.
The results showed that RAI treatment of DTC in childhood and adulthood was associated with several solid cancers.
associated with increased risk
.
Screenshot of the official website By analyzing the records of 9 US SEER cancer registries (1975-2017), the researchers used Poisson regression in non-metastatic DTC patients diagnosed before the age of 45 with a survival period of ≥5-years and ≥2-years, respectively.
The method estimated the relative risk (RR) of solid and hematological malignancies associated with RAI (yes, no, or unknown)
.
RESULTS: Among 27,050 survivors who survived ≥5 years (median follow-up = 15 years), RAI treatment (45%) was associated with an increased risk of solid malignancies (RR = 1.
23; 95% CI: 1.
11-1.
37) , the risk of uterine cancer (RR=1.
55; 95% CI: 1.
03-2.
32) was significantly increased, and there was no significant difference in the risk of salivary gland cancer, gastric cancer, lung cancer and female breast cancer
.
The risk of total solid cancer and female breast cancer (the most common cancer type) was highest among ≥20-year DTC survivors (RR solid cancer = 1.
47; 95% CI: 1.
24-1.
74; RR breast cancer = 1.
46; 95% CI: 1.
10-1.
95)
.
Among 32,171 survivors who survived ≥2 years, RAI was associated with an increased risk of hematological malignancies (RR=1.
51; 95% CI: 1.
08-2.
01), including leukemia (RR=1.
92; 95%CI: 1.
04-3.
56) )
.
The investigators estimated that among childhood and young adult DTC survivors, 6% of solid and 14% of hematologic malignancies were attributable to RAI
.
This study shows that, in addition to leukemia, RAI treatment of DTC in childhood and adulthood is associated with an increased risk of several solid cancers, especially more than 20 years after exposure, supporting the need for long-term monitoring of these patients
.
03New drug: KRAS inhibitor therapy corresponds to 100% disease control rate in patients with mutant pancreatic cancer and gastrointestinal cancer and other gastrointestinal (GI) cancer patients demonstrated effective disease control in KRYSTAL-1 clinical trial, with an objective response rate (ORR) of 41% in evaluable patients (n=27) as of September 10, 2021 , the disease control rate (DCR) was 100%
.
KARS, a GTPase, is a molecular switch, and Adagrasib is a highly specific and potent oral KRAS G12C inhibitor that locks KRAS G12C in an off state with a half-life of up to 24 hours and broad tissue distribution , and can cross the blood-brain barrier, with long-lasting target inhibition
.
In June last year, the U.
S.
Food and Drug Administration (FDA) granted it breakthrough therapy designation for the treatment of previously treated non-small cell lung cancer patients with the KRAS G12C mutation
.
In China, the clinical trial application jointly submitted by Zai Lab and Mirati was accepted on November 1 last year
.
04New drug: first-line treatment of advanced gastric cancer, natural killer cell therapy obtained fast track qualification Recently, Celularity announced that the US FDA has granted its genetically modified, cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy CYNK-101 fast track channel qualification
.
A Phase I/IIa clinical trial will evaluate this therapy in combination with standard chemotherapy, the anti-HER2 antibody trastuzumab, and the PD-1 inhibitor pembrolizumab in first-line treatment of locally advanced unresectable or metastatic HER2/neu Preliminary efficacy and safety in patients with positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
.
CYNK-101 is a placenta-derived allogeneic NK cell therapy genetically engineered to enhance antibody-dependent cellular cytotoxicity (ADCC) to synergize with approved antibody therapeutics
.
References: 1.
Preetesh J, et al.
Ibrutinib–rituximab followed by R-HCVAD as frontline treatment for young patients (≤65 years) with mantle cell lymphoma (WINDOW-1): a single-arm, phase 2 trial.
Lancet Oncol.
2022 Jan 21.
doi:10.
1016/S1470-2045(21)00638-0 https:// E, et al.
Association Between Radioactive Iodine Treatment for Pediatric and Young Adulthood Differentiated Thyroid Cancer and Risk of Second Primary Malignancies [published online ahead of print, 2022 Jan 19].
J Clin Oncol.
2022;JCO2101841.
doi:10.
1200/JCO.
21.
01841 https ://ascopubs.
org/doi/full/10.
1200/JCO.
21.
018413.
https://mp.
weixin.
qq.
com/s/LTjw27mOeujkR_4WZ0oGXg4.
https://celularity.
com/celularity-receives-fast-track-designation -from-us-fda-for-its-nk-cell-therapy-cynk-101/
.
Screenshot of the official website The researchers conducted a single-center, single-arm, phase II trial in patients with untreated mantle cell lymphoma
.
Eligible patients were aged 65 years and younger, serum bilirubin ≤1.
5 mg/dL, creatinine clearance ≤30 mL/min, Eastern Cooperative Oncology Group functional status score ≤2, echocardiographic cardiac ejection fraction ≥50%
.
Patients received 12 cycles of ibrutinib-rituximab induction (Part A; ibrutinib 560 mg orally daily and rituximab 375 mg/m2 weekly intravenously, weekly for the first 4 weeks , followed by Day 1 of Cycles 3-12)
.
Once the patient is in complete remission, four cycles of R-HCVAD alternating with methotrexate-cytarabine (Part B) are administered immediately
.
If patients did not have a complete response or had a partial response, they received two cycles of R-HCVAD alternating with methotrexate-cytarabine and then reassessed for a total of eight cycles
.
Patients were withdrawn from the study if their disease was stable or progressed while receiving R-HCVAD
.
The primary outcome showed the overall response rate after Part
A.
Results showed that 131 patients were enrolled between June 12, 2015, and December 6, 2018
.
Fifty-eight (50%) of 117 patients had high Ki-67 levels (≥30%)
.
129 of 131 patients (98%, 95% CI: 95-100) had a response in Part
A.
The most common grade 3-4 adverse events were lymphopenia (14%), rash (12%), thrombocytopenia (9%), infection (8%), and fatigue (8%) in part A and fatigue (8%) in part B.
Lymphopenia (73%), leukopenia (32%), thrombocytopenia (30%) and neutropenia (20%)
.
There was one death in the study, but it was not considered treatment-related
.
The results suggest that ibrutinib-rituximab induction is effective and safe for first-line treatment of young patients with mantle cell lymphoma
.
This approach minimizes the number of chemotherapy cycles and thus reduces chemotherapy-related adverse events
.
Introducing a Next-Generation Bruton's Tyrosine Kinase (BTK) Inhibitor to Frontline Therapy in New Clinical Trial May Completely Avoid the Need for Chemotherapy in Mantle Cell Lymphoma Patients
.
02JCO: Radioactive iodine therapy for thyroid cancer in children and adolescents is associated with increased risk of several solid tumors Since the 1980s, both the incidence of differentiated thyroid cancer (DTC) and the use of radioactive iodine (RAI) therapy have increased significantly
.
RAI has been shown to be associated with an increased risk of leukemia, but the risk of second solid malignancies is unknown, and children are more susceptible to the late effects of radiation than the elderly in older adults
.
Recently, a study investigating the risk of second primary malignancy in children and young adults associated with RAI treatment of DTC was published in the Journal of Clinical Oncology.
The results showed that RAI treatment of DTC in childhood and adulthood was associated with several solid cancers.
associated with increased risk
.
Screenshot of the official website By analyzing the records of 9 US SEER cancer registries (1975-2017), the researchers used Poisson regression in non-metastatic DTC patients diagnosed before the age of 45 with a survival period of ≥5-years and ≥2-years, respectively.
The method estimated the relative risk (RR) of solid and hematological malignancies associated with RAI (yes, no, or unknown)
.
RESULTS: Among 27,050 survivors who survived ≥5 years (median follow-up = 15 years), RAI treatment (45%) was associated with an increased risk of solid malignancies (RR = 1.
23; 95% CI: 1.
11-1.
37) , the risk of uterine cancer (RR=1.
55; 95% CI: 1.
03-2.
32) was significantly increased, and there was no significant difference in the risk of salivary gland cancer, gastric cancer, lung cancer and female breast cancer
.
The risk of total solid cancer and female breast cancer (the most common cancer type) was highest among ≥20-year DTC survivors (RR solid cancer = 1.
47; 95% CI: 1.
24-1.
74; RR breast cancer = 1.
46; 95% CI: 1.
10-1.
95)
.
Among 32,171 survivors who survived ≥2 years, RAI was associated with an increased risk of hematological malignancies (RR=1.
51; 95% CI: 1.
08-2.
01), including leukemia (RR=1.
92; 95%CI: 1.
04-3.
56) )
.
The investigators estimated that among childhood and young adult DTC survivors, 6% of solid and 14% of hematologic malignancies were attributable to RAI
.
This study shows that, in addition to leukemia, RAI treatment of DTC in childhood and adulthood is associated with an increased risk of several solid cancers, especially more than 20 years after exposure, supporting the need for long-term monitoring of these patients
.
03New drug: KRAS inhibitor therapy corresponds to 100% disease control rate in patients with mutant pancreatic cancer and gastrointestinal cancer and other gastrointestinal (GI) cancer patients demonstrated effective disease control in KRYSTAL-1 clinical trial, with an objective response rate (ORR) of 41% in evaluable patients (n=27) as of September 10, 2021 , the disease control rate (DCR) was 100%
.
KARS, a GTPase, is a molecular switch, and Adagrasib is a highly specific and potent oral KRAS G12C inhibitor that locks KRAS G12C in an off state with a half-life of up to 24 hours and broad tissue distribution , and can cross the blood-brain barrier, with long-lasting target inhibition
.
In June last year, the U.
S.
Food and Drug Administration (FDA) granted it breakthrough therapy designation for the treatment of previously treated non-small cell lung cancer patients with the KRAS G12C mutation
.
In China, the clinical trial application jointly submitted by Zai Lab and Mirati was accepted on November 1 last year
.
04New drug: first-line treatment of advanced gastric cancer, natural killer cell therapy obtained fast track qualification Recently, Celularity announced that the US FDA has granted its genetically modified, cryopreserved human placental hematopoietic stem cell-derived natural killer (NK) cell therapy CYNK-101 fast track channel qualification
.
A Phase I/IIa clinical trial will evaluate this therapy in combination with standard chemotherapy, the anti-HER2 antibody trastuzumab, and the PD-1 inhibitor pembrolizumab in first-line treatment of locally advanced unresectable or metastatic HER2/neu Preliminary efficacy and safety in patients with positive gastric or gastroesophageal junction (G/GEJ) adenocarcinoma
.
CYNK-101 is a placenta-derived allogeneic NK cell therapy genetically engineered to enhance antibody-dependent cellular cytotoxicity (ADCC) to synergize with approved antibody therapeutics
.
References: 1.
Preetesh J, et al.
Ibrutinib–rituximab followed by R-HCVAD as frontline treatment for young patients (≤65 years) with mantle cell lymphoma (WINDOW-1): a single-arm, phase 2 trial.
Lancet Oncol.
2022 Jan 21.
doi:10.
1016/S1470-2045(21)00638-0 https:// E, et al.
Association Between Radioactive Iodine Treatment for Pediatric and Young Adulthood Differentiated Thyroid Cancer and Risk of Second Primary Malignancies [published online ahead of print, 2022 Jan 19].
J Clin Oncol.
2022;JCO2101841.
doi:10.
1200/JCO.
21.
01841 https ://ascopubs.
org/doi/full/10.
1200/JCO.
21.
018413.
https://mp.
weixin.
qq.
com/s/LTjw27mOeujkR_4WZ0oGXg4.
https://celularity.
com/celularity-receives-fast-track-designation -from-us-fda-for-its-nk-cell-therapy-cynk-101/
