- Pei Jye Voon (Kuching, MY)
- Bhumsuk Keam (Seoul, KR)
357MO - Comparison of long-term quality of life between survivors of adolescent and adult nasopharyngeal carcinoma
- Liting Liu (Guangzhou, CN)
- Jing Jin (Guangzhou, CN)
- Qiu yan Chen (Guangzhou, CN)
- Liting Liu (Guangzhou, CN)
- Shan-Shan Guo (Guangzhou, CN)
- Dong Xiang Wen (Guangzhou, CN)
- Jie Yi Lin (guangzhou, CN)
- Jin Hao Yang (guangzhou, CN)
- Ru Li (guangzhou, CN)
Abstract
Background
Nasopharyngeal carcinoma (NPC) is not commonly observed in adolescents. The late sequelae and long-term survival outcomes diverge between adult and adolescent survivors of NPC. This study was to compare the differences between these two cohorts and evaluate the socio-demographic and clinical factors that have the most significant impact on different aspects of quality of life.
Methods
A total of 420 survivors could be included (195 adolescent and 225 adult survivors). To balance the influence of covariates and potential bias, we used the propensity score matching (PSM) method to match adolescent and adult patients at a ratio of 1:1. Ultimately, we included 155 adolescent and 155 adult survivors in the subsequent analysis. The EORTC QLQ-C30 consists of 30 items spread across 15 dimensions, comprising of 5 functional dimensions, 1 dimension measuring Global health status/QoL, and individual symptom items. The functioning and QoL scales are such that a higher score indicates better health, whereas a higher score on the symptom scales indicates a higher severity of symptoms.
Results
In terms of Global health status, adolescent patients had higher scores than those of adult patients (adolescent: 80.2±12.7; adult: 77.2±11.5; P=0.027). Furthermore, there were also differences in the Functional Scale/Items. Adolescent patients scored higher in Physical functioning (adolescent: 98.5±4.6; adult: 95.1±7.0; P<0.001), Role functioning (adolescent: 97.0±9.2; adult: 90.5±15.2; P<0.001),and Social functioning (adolescent: 96.0±9.0; adult: 93.5±11.8; P=0.038) but had worse Cognitive functioning (adolescent: 88.3±9.9; adult: 93.8±12.6; P<0.001) scores than adult patients. There were also differences in the symptom scale/items, including insomnia (adolescent: 1.9±7.8; adult: 13.1±22.3; P<0.001), constipation (adolescent: 1.29±7.5; adult: 8.0±17.4; P<0.001) and diarrhea (adolescent: 0.65±4.6; adult: 2.8±9.2; P=0.010).
Conclusions
We can infer that adolescent NPC patients are a particular group of patients that, compared to adult patients achieve better survival outcomes, and experience less treatment-related long-term toxicity, and a higher quality of life in the long term.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
358MO - Quality-adjusted life-year and life-year estimates for patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the combined positive score 1-19 subgroup treated with pembrolizumab +/- chemotherapy vs cetuximab-containing regimens
- Philipp Ivanyi (Hannover, DE)
- Philipp Ivanyi (Hannover, DE)
- Ash Bullement (Nottingham, GB)
- Michael Schlichting (Darmstadt, DE)
- Jaesh Naik (Nottingham, GB)
- Christopher P. Pescott (Darmstadt, DE)
Abstract
Background
KEYNOTE-048 (NCT02358031) compared pembrolizumab (P) +/- chemotherapy (CT) with cetuximab + platinum-based CT for patients with recurrent and/or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN). The estimated effect size for PFS and OS varied by combined positive score (CPS) subgroup. Focusing on CPS 1-19, we performed (in)direct treatment comparisons to quantify differences in quality-adjusted life-year (QALY) and life year (LY) gains for P +/- CT vs. cetuximab-containing regimens, EXTREME and TPEx (CCRs).
Methods
Five published trials reporting relevant data were identified (KEYNOTE-048 [CPS 1-19], EXTREME [all patients, NCT00122460], TPEXTREME [all patients, NCT02268695], GORTEC [all patients, NCT01289522], and CHECKMATE-651 [all patients, NCT02741570]). To estimate QALY gains, parametric models were fitted to digitized OS and PFS data from each trial, extrapolated to a lifetime horizon and combined with published utility values, accounting for time-preference discount rates from an Italian perspective. We compared incremental QALYs and LYs for P +/- CT and P, vs. both CCRs for the CPS 1-19 subgroup.
Results
Applying parametric models with the best statistical goodness-of-fit scores, changing the source of data for CCRs yielded LY and QALY gains in the range of -0.63 to +0.60 and -0.35 to +0.39, respectively, when compared with P+CT. Versus P alone, the corresponding ranges were -0.72 to +0.50 (LYs) and -0.45 to +0.29 (QALYs).
Conclusions
Since variability in outcomes for CCRs has been observed between trials, incremental QALY and LY estimates for subgroup analyses differ depending on the trial data used to project them. Additional evidence from indirect comparisons could better inform the relative effectiveness of P +/- CT vs. CCRs, for patients with CPS 1-19 R/M SCCHN, with important clinical implications.
Legal entity responsible for the study
Merck Healthcare KGaA, Darmstadt, Germany.
Funding
Merck Healthcare KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/1000099450.
Disclosure
P. Ivanyi: Financial Interests, Personal, Advisory Role: BMS, Bayer, Clinsol, Deciphera, Eisai, EMD Serono Inc., EUSA Pharma, H5-Oncology, Ipsen, Merck Serono (Global), Metaplan, MSD, Onkowissen, Pfizer, Roche; Financial Interests, Personal, Invited Speaker: AIM, Apogepha, AstraZeneca, Astella, BMS, Bayer (+ Europe, Global), CORE2ED, Deciphera, DKG-Onkoweb, Eisai, EUSA Pharma, FoFM, Id-Institut, Ipsen (Europe), Merck Serono (+ Europe, Global), MSD, MedKom, MTE-Academy, MedWiss, New Concept Oncology, Onkowissen-tv.de, Pharma Mare, Pfizer, Roche, ThinkWired!, Schmitz-Communikation, StreamedUP!, Solution Academy, Vivantis; Financial Interests, Personal, Research Grant: AIO, AstraZeneca, BMS, GSK, Ipsen, Lilly, Merck Serono, Niedersächsische Krebsgesellschaft, Novartis, EUSA, Eisai, Pfizer, MSD, Roche, Stiftung Immunonkologie, Wilhelm Sander Stiftung; Financial Interests, Personal, Funding: BB-Biotech, BMS, Bayer, Deutsche Gesellschaft für Thoraxchirurgie, EUSA, EUSA, Merck, Pharma Mare; Non-Financial Interests, Personal, Member: Member of Germen Working Party Medical Oncology (AIO), Member of the German Cancer Society, ASCO Member, ESMO Member, Member of Oncological Working Party Hannover (OAK), Spokesman Interdisciplinary Working Party – Kidney Cancer (IAGN-DKG); Non-Financial Interests, Personal, Steering Committee Member: Immunooncology Cooperative Group (ICOG-H), Clinical Trial Steering Committee CCC-H. A. Bullement, J. Naik: Financial Interests, Personal, Affiliate: Delta Hat . M. Schlichting, C.P. Pescott: Financial Interests, Personal, Affiliate: Merck Healthcare KGaA.
Invited Discussant 357MO and 358MO
- Pei Jye Voon (Kuching, MY)
- Pei Jye Voon (Kuching, MY)
Q&A and discussion
- All Speakers (Lugano, CH)
- All Speakers (Lugano, CH)
359MO - Phase I dose-escalation study of nab-paclitaxel combined with cisplatin and capecitabin as induction chemotherapy followed by concurrent chemoradiotherapy in patients with nasopharyngeal carcinoma
- Shan-Shan Guo (Guangzhou, CN)
- Shan-Shan Guo (Guangzhou, CN)
- Qiu yan Chen (Guangzhou, CN)
- Liting Liu (Guangzhou, CN)
- Rui Sun (Guangzhou, CN)
- Pan Wang (Guangzhou, CN)
- DongMei Li (Guangzhou, CN)
Abstract
Background
Nab-paclitaxel is a promising albumin-bound paclitaxel with a therapeutic index superior to that of docetaxel, but the optimal dose of nab-paclitaxel combined with cisplatin and capecitabine as induction chemotherapy followed by concurrent chemoradiotherapy for patients with locally advanced nasopharyngeal carcinoma remains unknown.
Methods
This was an open-label, single-arm study investigating the safety and efficacy of nab-paclitaxel+cisplatin+capecitabin as IC for three cycles, followed by cisplatin CCRT, conducted by using the standard “3 + 3” design in LA-NPC. If more than one-third of the patients in a cohort experienced dose-limiting toxicity (DLT), the dose used in the previous cohort was designated the maximum tolerated dose (MTD). The recommended phase 2 dose (RP2D) was defined as one level below the MTD.
Results
From 29 May 2021 to 17 March 2022, 19 patients with LA-NPC were enrolled, one patient withdrew informed consent. Two DLTs occurred in cohort 4 (grade 4 febrile neutropenia and grade 3 peripheral neuropathy), and an MTD was established as 225 mg/m2. The most frequent grade 3 or 4 adverse events were neutropenia (16.7%), hypertriglyceridemia (16.7%), leukopenia (5.6%) and peripheral neuropathy (5.6%) during IC.
Conclusions
The RP2D is nab-paclitaxel 200 mg/m2 on day 1, combined with cisplatin 75 mg/mg2 on day 1 and capecitabin1000 mg/m2 on days 1–14, twice a day, every 3 weeks, for three cycles as an IC regimen prior to CCRT.
Clinical trial identification
NCT04850235.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
360MO - Pembrolizumab plus nab-paclitaxel and platinum as first-line treatment in patients with recurrent or metastatic head and neck squamous-cell carcinoma (R/M HNSCC): A prospective phase II study
- Xinrui Chen (Beijing, CN)
- Lin Gui (Beijing, CN)
- Xinrui Chen (Beijing, CN)
- XiaoHui He (Beijing, CN)
- Jianliang Yang (Beijing, CN)
- Peng Liu (Beijing, CN)
- Yan Qin (Beijing, CN)
- Yuan-Kai Shi (Beijing, CN)
Abstract
Background
Pembrolizumab plus platinum and fluorouracil is the standard first-line treatment in patients with R/M HNSCC. The KN-B10 study alsoconfirmed that pembrolizumab combined with carboplatin and paclitaxel has a good effect. Therefore, it is considered that PD-1 combined-with platinum and paclitaxel is a possible alternative for first-line treatment.
Methods
Patients with untreated R/M HNSCC and with ≥1 measurable lesion according to RECIST 1.1 were included. Patients received pembro 200mg, nab-paclitaxel 260mg/m2 plus cisplatin 75 mg/m2 on day 1 every 21 days for up to six cycles followed by pembro maintenance therapy until progression or unacceptable toxicity or 35 cycles, whichever occurred first. The primary endpoint was overall response rate (ORR). Secondary endpoints comprised safety, disease control rate (DCR), overall survival (OS) and progression free survival (PFS).
Results
From April 30, 2021 until August 22 2023, 30 patients were enrolled. Baseline information was shown in the table. Six patients (20%) achieved complete response, ORR was 63.3% and the DCR was 96.7%. Median follow-up was 14.5 months, the median PFS was 12.3-months and the median OS was not reached. One patient had immune-related grade 3 diarrhea, which improved after symptomatic-treatment. One patient discontinued treatment due to immune-related grade 3 pneumonia, and then continued immunotherapy. The most common non-hematological toxicity was hypothyroidism.
Patient number 30 Median (range) 57 (38-73) Gender (male / female) 29 / 1 0 6 (20.0%) 1 20 (66.7%) 2 4 (13.3%) Hypopharynx 8 (26.7%) Larynx 9 (30.0%) Oropharynx 5 (16.7%) Oral cavity 8 (26.7%) < 1 1 (3.3%) 1-20 11 (36.7%) ≥20 15 (50.0%) Unknow 3 (10.0%) ≥10 2 (6.7%) ＜10 8 (26.7%) Unknow 20 (66.7%) Distant metastatic disease 9 (30.0%) Local disease 11 (36.7%) Distant and local diseases 10 (33.3%)
Conclusions
Pembrolizumab in combination with nab-paclitaxel and platinum showed prolonged survival in untreated R/M HNSCC patients, while nonew toxicities were identified.
Clinical trial identification
NCT04857164; April 23, 2021.
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
361MO - Characterizing the role of NSD family of histone methyltransferases in the head and neck squamous cell carcinoma tumor immune microenvironment
- Yanis Boumber (Birmingham, US)
- Yanis Boumber (Birmingham, US)
- Sachin Kumar Deshmukh (Irving, US)
- Sharon Wu (Irving, US)
- Joanne Xiu (Phoenix, US)
- Alex Farrell (Irving, US)
- Aakash Desai (Birmingham, US)
- Chul Kim (Washington, US)
- Farah Abdulla (Irving, US)
- Ari Vanderwalde (Irving, US)
- Trisha Wise-Draper (Cincinnati, US)
- Jennifer M. Johnson (Philadelphia, US)
Abstract
Background
Head neck squamous cell carcinomas (HNSCC) are aggressive tumors, with biologic and genetic diversity contributing to pathogenesis, disease course, and responses to treatment. While loss of function mutations in
Methods
2,292 HNSCC samples were analyzed by NGS (592, NextSeq; WES, NovaSeq), WTS (NovaSeq) (Caris Life Sciences). HPV status inferred by staining of p16 by IHC. Tumor mutational burden (TMB) totaled somatic mutations per tumor (high>10 mt/MB). Immune cell fractions were calculated by deconvolution of WTS: Quantiseq. HNSCC with
Results
Conclusions
Our data suggest a strong association between
Legal entity responsible for the study
The author.
Funding
Caris Life Sciences.
Disclosure
The author has declared no conflicts of interest.
Invited Discussant 359MO, 360MO and 361MO
- Bhumsuk Keam (Seoul, KR)
- Bhumsuk Keam (Seoul, KR)
Q&A and discussion
- All Speakers (Lugano, CH)
- All Speakers (Lugano, CH)