Annals of OncologyPub Date : 2024-11-04DOI: 10.1016/j.annonc.2024.10.003
J H W de Wilt, D E W van der Kruijssen, M Koopman
{"title":"Reply to Letter to the Editor \"Optimising Treatment Strategies in Metastatic Colorectal Cancer: Insights from CAIRO4\" by Güzel et al.","authors":"J H W de Wilt, D E W van der Kruijssen, M Koopman","doi":"10.1016/j.annonc.2024.10.003","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.10.003","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-11-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142581921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-28DOI: 10.1016/j.annonc.2024.10.018
L A Huppert, D Wolf, C Yau, L Brown-Swigart, G L Hirst, C Isaacs, L Pusztai, P R Pohlmann, A DeMichele, R Shatsky, D Yee, A Thomas, R Nanda, J Perlmutter, D Heditsian, N Hylton, F Symmans, L J van 't Veer, L Esserman, H S Rugo
{"title":"Pathologic complete response (pCR) rates for patients with HR+/HER2- high-risk, early-stage breast cancer (EBC) by clinical and molecular features in the phase II I-SPY2 clinical trial.","authors":"L A Huppert, D Wolf, C Yau, L Brown-Swigart, G L Hirst, C Isaacs, L Pusztai, P R Pohlmann, A DeMichele, R Shatsky, D Yee, A Thomas, R Nanda, J Perlmutter, D Heditsian, N Hylton, F Symmans, L J van 't Veer, L Esserman, H S Rugo","doi":"10.1016/j.annonc.2024.10.018","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.10.018","url":null,"abstract":"<p><strong>Background: </strong>Hormone receptor positive (HR+), HER2- early-stage breast cancer (EBC) is a heterogenous disease. Identification of better clinical and molecular biomarkers is essential to guide optimal therapy for each patient.</p><p><strong>Patients and methods: </strong>We analyzed rates of pathologic complete response (pCR) and distant recurrence-free survival (DRFS) for patients with HR+/HER2- EBC in 8 neoadjuvant arms in the I-SPY2 trial by clinical/molecular features: age, stage, histology, percentage ER positivity, ER/PR status, MammaPrint (MP)-High1 (0 to -0.57) versus MP-High2 (<-0.57), BluePrint (BP)-Luminal-type versus BP-Basal-type, and ImPrint immune signature. We quantified the clinical/molecular heterogeneity, assessed overlap among these biomarkers, and evaluated associations with pCR and DRFS.</p><p><strong>Results: </strong>379 patients with HR+/HER2- EBC were included in this analysis, with an observed pCR rate of 17% across treatment arms. pCR rates were higher in patients with stage II versus III disease (21% versus 9%, p=0.0013), ductal versus lobular histology (19% versus 11%, p=0.049), lower %ER positivity (≤66% versus >66%) (35% versus 9%, p=3.4E-09), MP-High2 versus MP-High1 disease (31% versus 11%, p=1.1E-05), BP-Basal-type versus BP-Luminal-type disease (34% versus 10%, p=1.62E-07), and ImPrint positive versus negative disease (38% versus 10%, p=1.64E-09). Patients with lower %ER were more likely to have MP-High2 and BP-Basal-type disease. At a median follow-up of 4.8 years, patients who achieved pCR had excellent outcomes irrespective of clinical/molecular features. Among patients who did not achieve pCR, DRFS events were more frequent in patients with MP-High2 and BP-Basal-type disease than those with MP-High1 and BP-Luminal-type disease.</p><p><strong>Conclusion: </strong>Among patients with high molecular-risk HR+/HER2- EBC, the MP-High2, BP-Basal-type, and ImPrint positive signatures identified a partially overlapping subset of patients who were more likely to achieve pCR in response to neoadjuvant chemotherapy +/- targeted agents or immunotherapy compared to patients with MP-High1, BP-Luminal-type, and ImPrint negative disease. I-SPY2.2 is incorporating the use of these biomarkers to molecularly define specific patient populations and optimize treatment selection.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142543237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-25DOI: 10.1016/j.annonc.2024.10.017
K Jordan
{"title":"Beyond the Usual Window: Persistent Nausea with Trastuzumab Deruxtecan Calls for New Management Strategies.","authors":"K Jordan","doi":"10.1016/j.annonc.2024.10.017","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.10.017","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142567904","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-24DOI: 10.1016/j.annonc.2024.09.014
{"title":"TNT for organ preservation in rectal cancer: still looking for the right schedule and patient","authors":"","doi":"10.1016/j.annonc.2024.09.014","DOIUrl":"10.1016/j.annonc.2024.09.014","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493384","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-24DOI: 10.1016/j.annonc.2024.09.006
{"title":"KEYNOTE-B21: a missed opportunity or a turning point in adjuvant immunotherapy for dMMR endometrial cancer?","authors":"","doi":"10.1016/j.annonc.2024.09.006","DOIUrl":"10.1016/j.annonc.2024.09.006","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493382","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-24DOI: 10.1016/j.annonc.2024.07.731
{"title":"Paving the path towards tissue-agnostic drug approval in oncology","authors":"","doi":"10.1016/j.annonc.2024.07.731","DOIUrl":"10.1016/j.annonc.2024.07.731","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-21DOI: 10.1016/j.annonc.2024.10.015
G N Hortobagyi, A Lacko, J Sohn, F Cruz, M Ruiz Borrego, A Manikhas, Y Hee Park, D Stroyakovskiy, D A Yardley, C-S Huang, P A Fasching, J Crown, A Bardia, S Chia, S-A Im, M Martin, S Loi, B Xu, S Hurvitz, C Barrios, M Untch, R Moroose, F Visco, F Parnizari, J P Zarate, Z Li, S Waters, A Chakravartty, D Slamon
{"title":"A phase III trial of adjuvant ribociclib plus endocrine therapy vs endocrine therapy alone in patients with HR+/HER2- early breast cancer: final invasive disease-free survival results from the NATALEE trial.","authors":"G N Hortobagyi, A Lacko, J Sohn, F Cruz, M Ruiz Borrego, A Manikhas, Y Hee Park, D Stroyakovskiy, D A Yardley, C-S Huang, P A Fasching, J Crown, A Bardia, S Chia, S-A Im, M Martin, S Loi, B Xu, S Hurvitz, C Barrios, M Untch, R Moroose, F Visco, F Parnizari, J P Zarate, Z Li, S Waters, A Chakravartty, D Slamon","doi":"10.1016/j.annonc.2024.10.015","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.10.015","url":null,"abstract":"<p><strong>Background: </strong>NATALEE assessed efficacy and tolerability of 3 years of adjuvant ribociclib plus NSAI compared with a nonsteroidal aromatase inhibitor (NSAI) alone in a broad population of patients with HR+/HER2- early breast cancer, including a select group without nodal involvement. This is the final preplanned analysis of invasive disease-free survival (iDFS).</p><p><strong>Patients and methods: </strong>Premenopausal/postmenopausal women and men were randomized 1:1 to ribociclib (n=2549; 400 mg/day, 3 weeks on/1 week off for 36 months) plus NSAI (letrozole 2.5 mg/day or anastrozole 1 mg/day for 60 months) or NSAI alone (n=2552). Men and premenopausal women also received goserelin (3.6 mg once every 28 days). Patients had anatomical stage IIA (N0 with additional risk factors or N1), IIB, or III disease. The primary endpoint was iDFS. Secondary efficacy endpoints were recurrence-free survival (RFS), distant DFS (DDFS), and overall survival (OS). This final iDFS analysis was planned after ≈500 events.</p><p><strong>Results: </strong>At data cutoff (21 July 2023), ribociclib was stopped for 1996 patients (78.3%); 1091 (42.8%) completed 3 years of ribociclib, and ribociclib treatment was ongoing for 528 (20.7%). Median follow-up for iDFS was 33.3 months. Overall, 226 and 283 iDFS events occurred with ribociclib plus NSAI vs NSAI alone, respectively. Ribociclib plus NSAI demonstrated significant iDFS benefit over NSAI alone (Hazard Ratio 0.749, 95% Confidence Interval [CI] 0.628-0.892; P=0.0012). The 3-year iDFS rates were 90.7% (95% CI 89.3%-91.8%) vs 87.6% (95% CI 86.1%-88.9%). A consistent benefit was observed across prespecified subgroups, including stage (II/III) and nodal status (+/-). DDFS and RFS favored ribociclib plus NSAI. OS data were immature. No new safety signals were observed.</p><p><strong>Conclusions: </strong>With longer follow-up and most patients off ribociclib, NATALEE continues to demonstrate iDFS benefit with ribociclib plus NSAI over NSAI alone in the overall population and across key subgroups. Observed adverse events remained stable.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-21DOI: 10.1016/j.annonc.2024.09.018
J-Y Blay, N Penel, C Schiffler, S Chabaud, D Perol, A Le Cesne
{"title":"Six years duration of adjuvant imatinib improves disease-free survival in GIST with a high risk of relapse.","authors":"J-Y Blay, N Penel, C Schiffler, S Chabaud, D Perol, A Le Cesne","doi":"10.1016/j.annonc.2024.09.018","DOIUrl":"https://doi.org/10.1016/j.annonc.2024.09.018","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493381","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-21DOI: 10.1016/j.annonc.2024.10.016
T M Kim, A Chaudhry, H Mohamed, B Shen, S Ambati
{"title":"Reply to the Letter to the Editor \"Odronextamab against relapsed or refractory follicular lymphoma\" by Y. Shimazu.","authors":"T M Kim, A Chaudhry, H Mohamed, B Shen, S Ambati","doi":"10.1016/j.annonc.2024.10.016","DOIUrl":"10.1016/j.annonc.2024.10.016","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493467","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annals of OncologyPub Date : 2024-10-16DOI: 10.1016/j.annonc.2024.10.012
M Martín, S R Stecklein, O Gluz, G Villacampa, M Monte-Millán, U Nitz, S Cobo, M Christgen, F Brasó-Maristany, E L Álvarez, I Echavarría, B Conte, S Kuemmel, C Bueno-Muiño, Y Jerez, R Kates, M Cebollero, C Kolberg-Liedtke, O Bueno, J Á García-Saenz, F Moreno, E-M Grischke, H Forstbauer, M Braun, M Warm, J Hackmann, C Uleer, B Aktas, C Schumacher, R Wuerstleins, M Graeser, C Zu Eulenburg, H H Kreipe, H Gómez, T Massarrah, B Herrero, L Paré, U Bohn, S López-Tarruella, A Vivancos, E Sanfeliu, J S Parker, C M Perou, P Villagrasa, A Prat, P Sharma, N Harbeck
{"title":"TNBC-DX genomic test in early-stage triple-negative breast cancer treated with neoadjuvant taxane-based therapy.","authors":"M Martín, S R Stecklein, O Gluz, G Villacampa, M Monte-Millán, U Nitz, S Cobo, M Christgen, F Brasó-Maristany, E L Álvarez, I Echavarría, B Conte, S Kuemmel, C Bueno-Muiño, Y Jerez, R Kates, M Cebollero, C Kolberg-Liedtke, O Bueno, J Á García-Saenz, F Moreno, E-M Grischke, H Forstbauer, M Braun, M Warm, J Hackmann, C Uleer, B Aktas, C Schumacher, R Wuerstleins, M Graeser, C Zu Eulenburg, H H Kreipe, H Gómez, T Massarrah, B Herrero, L Paré, U Bohn, S López-Tarruella, A Vivancos, E Sanfeliu, J S Parker, C M Perou, P Villagrasa, A Prat, P Sharma, N Harbeck","doi":"10.1016/j.annonc.2024.10.012","DOIUrl":"10.1016/j.annonc.2024.10.012","url":null,"abstract":"<p><strong>Background: </strong>Identification of biomarkers to optimize treatment strategies for early-stage triple-negative breast cancer (TNBC) is crucial. This study presents the development and validation of TNBC-DX, a novel test aimed at predicting both short- and long-term outcomes in early-stage TNBC. The objective of this study was to evaluate the association between TNBC-DX and efficacy outcomes [pathologic complete response (pCR), distant disease-free survival (DDFS) or event-free survival (EFS), and overall survival (OS)] in the validation cohorts.</p><p><strong>Methods: </strong>Information from 1259 patients with early-stage TNBC (SCAN-B, CALGB-40603, and BrighTNess) was used to establish the TNBC-DX scores. Independent validation of TNBC-DX was carried out in three studies: (i) WSG-ADAPT-TN; (ii) MMJ-CAR-2014-01; and (iii) NeoPACT, including 527 patients with stage I-III TNBC undergoing neoadjuvant chemotherapy. In WSG-ADAPT-TN, patients were randomized to receive nab-paclitaxel plus gemcitabine or carboplatin. In MMJ-CAR-2014-01, patients received carboplatin plus docetaxel. In NeoPACT, patients received carboplatin plus docetaxel and pembrolizumab.</p><p><strong>Results: </strong>TNBC-DX test was created incorporating the 10-gene Core Immune Gene module, the 4-gene tumor cell proliferation signature, tumor size, and nodal staging. In the two independent validation cohorts without pembrolizumab, the TNBC-DX pCR score was significantly associated with pCR after adjustment for clinicopathological variables and treatment regimen [odds ratio per 10-unit increment 1.34, 95% confidence interval (CI) 1.20-1.52, P < 0.001]. pCR rates for the TNBC-DX pCR-high, pCR-medium, and pCR-low categories were 56.3%, 53.6%, and 22.5% respectively (odds ratio for pCR-high versus pCR-low 3.48, 95% CI 1.72-7.15, P < 0.001). In addition, the TNBC-DX risk score was significantly associated with DDFS [hazard ratio (HR) high-risk versus low-risk 0.24, 95% CI 0.15-0.41, P < 0.001] and OS (HR 0.19, 95% CI 0.11-0.35, P < 0.001). In the validation cohort with pembrolizumab, the TNBC-DX scores were significantly associated with pCR, EFS, and OS.</p><p><strong>Conclusions: </strong>TNBC-DX predicts pCR to neoadjuvant taxane-carboplatin in stage I-III TNBC and helps to forecast the patient's long-term survival in the absence of neoadjuvant anthracycline-cyclophosphamide, and independent of pembrolizumab use.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":null,"pages":null},"PeriodicalIF":56.7,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142456514","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}