Journal of Clinical Oncology最新文献

{"title":"Nodal Burden and Oncologic Outcomes in Patients With Residual Isolated Tumor Cells After Neoadjuvant Chemotherapy (ypN0i+): The OPBC-05/ICARO Study.","authors":"Giacomo Montagna, Alison Laws, Massimo Ferrucci, Mary M Mrdutt, Susie X Sun, Suleyman Bademler, Hakan Balbaloglu, Nora Balint-Lahat, Maggie Banys-Paluchowski, Andrea V Barrio, John Benson, Nuran Bese, Judy C Boughey, Marissa K Boyle, Emilia J Diego, Claire Eden, Ruth Eller, Maite Goldschmidt, Callie Hlavin, Martin Heidinger, Justyna Jelinska, Güldeniz Karadeniz Cakmak, Susan B Kesmodel, Tari A King, Henry M Kuerer, Julie Loesch, Francesco Milardi, Dawid Murawa, Tracy-Ann Moo, Tehillah S Menes, Daniele Passeri, Jessica M Pastoriza, Andraz Perhavec, Nina Pislar, Natália Polidorio, Avina Rami, Jai Min Ryu, Alexandra Schulz, Varadan Sevilimedu, M Umit Ugurlu, Cihan Uras, Annemiek van Hemert, Stephanie M Wong, Tae-Kyung Robyn Yoo, Jennifer Q Zhang, Hasan Karanlik, Neslihan Cabioğlu, Marie-Jeanne Vrancken Peeters, Monica Morrow, Walter P Weber","doi":"10.1200/JCO.24.01052","DOIUrl":"10.1200/JCO.24.01052","url":null,"abstract":"<p><strong>Purpose: </strong>The nodal burden of patients with residual isolated tumor cells (ITCs) in the sentinel lymph nodes (SLNs) after neoadjuvant chemotherapy (NAC) (ypN0i+) is unknown, and axillary management is not standardized. We investigated rates of additional positive lymph nodes (LNs) at axillary lymph node dissection (ALND) and oncologic outcomes in patients with ypN0i+ treated with and without ALND.</p><p><strong>Methods: </strong>The Oncoplastic Breast Consortium-05/ICARO cohort study (ClinicalTrials.gov identifier: NCT06464341) retrospectively analyzed data from patients with stage I to III breast cancer with ITCs in SLNs after NAC from 62 centers in 18 countries. The primary end point was the 3-year rate of any axillary recurrence. The rate of any invasive recurrence was the secondary end point.</p><p><strong>Results: </strong>In total, 583 patients were included, of whom 182 (31%) had completion ALND and 401 (69%) did not. The median age was 48 years. Most patients (74%) were clinically node-positive at diagnosis and 41% had hormone receptor-positive/human epidermal growth factor receptor 2-negative tumors. The mean number of SLNs with ITCs was 1.2. Patients treated with ALND were more likely to present with cN2/3 disease (17% <i>v</i> 7%, <i>P</i> < .001), have ITCs detected on frozen section (62% <i>v</i> 8%, <i>P</i> < .001), have lymphovascular invasion (38% <i>v</i> 24%, <i>P</i> < .001), and receive adjuvant chest wall (89% <i>v</i> 78%, <i>P</i> = .024) and nodal radiation (82% <i>v</i> 75%, <i>P</i> = .038). Additional positive nodes were found at ALND in 30% of patients, but only 5% had macrometastases. The 3-year rates of any axillary and any invasive recurrence were 2% (95% CI, 0.95 to 3.6) and 11% (95% CI, 8 to 14), respectively, with no statistical difference by type of axillary surgery.</p><p><strong>Conclusion: </strong>The nodal burden in patients with ypN0(i+) was low, and axillary recurrence after ALND omission was rare in patients selected for this approach. These results do not support routine ALND in all patients with ypN0(i+).</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"810-820"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11856002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142604659","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Neoadjuvant Chemotherapy for Newly Diagnosed, Advanced Ovarian Cancer: ASCO Guideline Update.","authors":"Stéphanie Gaillard, Christina Lacchetti, Deborah K Armstrong, William A Cliby, Mitchell I Edelson, Agustin A Garcia, Rahel G Ghebre, Gregory M Gressel, Jamie L Lesnock, Larissa A Meyer, Kathleen N Moore, Roisin E O'Cearbhaill, Alexander B Olawaiye, Ritu Salani, Dee Sparacio, Willemien J van Driel, William P Tew","doi":"10.1200/JCO-24-02589","DOIUrl":"10.1200/JCO-24-02589","url":null,"abstract":"<p><strong>Purpose: </strong>To provide updated guidance regarding neoadjuvant chemotherapy (NACT) and primary cytoreductive surgery (PCS) among patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (epithelial ovarian cancer [EOC]).</p><p><strong>Methods: </strong>A multidisciplinary Expert Panel convened and updated the systematic review.</p><p><strong>Results: </strong>Sixty-one studies form the evidence base.</p><p><strong>Recommendations: </strong>Patients with suspected stage III-IV EOC should be evaluated by a gynecologic oncologist, with cancer antigen 125, computed tomography of the abdomen and pelvis, and chest imaging included. All patients with EOC should be offered germline genetic and somatic testing at diagnosis. For patients with newly diagnosed advanced EOC who are fit for surgery and have a high likelihood of achieving complete cytoreduction, PCS is recommended. For patients fit for PCS but deemed unlikely to have complete cytoreduction, NACT is recommended. Patients with newly diagnosed advanced EOC and a high perioperative risk profile should receive NACT. Before NACT, patients should have histologic confirmation of invasive ovarian cancer. For NACT, a platinum-taxane doublet is recommended. Interval cytoreductive surgery (ICS) should be performed after ≤four cycles of NACT for patients with a response to chemotherapy or stable disease. For patients with stage III disease, good performance status, and adequate renal function treated with NACT, hyperthermic intraperitoneal chemotherapy may be offered during ICS. After ICS, chemotherapy should continue to complete a six-cycle treatment plan with the optional addition of bevacizumab. Patients with EOC should be offered US Food and Drug Administration-approved maintenance treatments. Patients with progressive disease on NACT should have diagnosis reconfirmed via tissue biopsy. Patients without previous comprehensive genetic or molecular profiling should be offered testing. Treatment options include alternative chemotherapy regimens, clinical trials, and/or initiation of end-of-life care.Additional information is available at www.asco.org/gynecologic-cancer-guidelines.This guideline has been endorsed by the Society of Gynecologic Oncology.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"868-891"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143023598","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}

{"title":"Onvansertib in Combination With Chemotherapy and Bevacizumab in Second-Line Treatment of <i>KRAS</i>-Mutant Metastatic Colorectal Cancer: A Single-Arm, Phase II Trial.","authors":"Daniel H Ahn, Maya Ridinger, Timothy L Cannon, Lawrence Mendelsohn, Jason S Starr, Joleen M Hubbard, Anup Kasi, Afsaneh Barzi, Errin Samuëlsz, Anju Karki, Ramanand A Subramanian, Divora Yemane, Roy Kim, Chu-Chiao Wu, Peter J P Croucher, Tod Smeal, Fairooz F Kabbinavar, Heinz-Josef Lenz","doi":"10.1200/JCO-24-01266","DOIUrl":"10.1200/JCO-24-01266","url":null,"abstract":"<p><strong>Purpose: </strong>This phase II study evaluated the efficacy and tolerability of onvansertib, a polo-like kinase 1 (PLK1) inhibitor, in combination with fluorouracil, leucovorin, and irinotecan (FOLFIRI) + bevacizumab for the second-line treatment of <i>KRAS</i>-mutant metastatic colorectal cancer (mCRC).</p><p><strong>Patients and methods: </strong>This multicenter, open-label, single-arm study enrolled patients with <i>KRAS</i>-mutated mCRC previously treated with oxaliplatin and fluorouracil with or without bevacizumab. Patients received onvansertib (15 mg/m² once daily on days 1-5 and 15-19 of a 28-day cycle) and FOLFIRI + bevacizumab (days 1 and 15). The primary end point was the objective response rate (ORR), and secondary endpoints included progression-free survival (PFS), duration of response (DOR), and tolerability. Translational and preclinical studies were conducted in <i>KRAS</i>-mutant CRC.</p><p><strong>Results: </strong>Among the 53 patients treated, the confirmed ORR was 26.4% (95% CI, 15.3 to 40.3). The median DOR was 11.7 months (95% CI, 9.4 to not reached). Grade 3/4 adverse events were reported in 62% of patients. A post hoc analysis revealed that patients with no prior bevacizumab treatment had a significantly higher ORR and longer PFS compared with patients with prior bevacizumab treatment: ORR of 76.9% versus 10.0% (odds ratio of 30.0, <i>P</i> < .001) and median PFS of 14.9 months versus 6.6 months (hazard ratio of 0.16, <i>P</i> < .001). Our translational findings support that prior bevacizumab exposure contributes to onvansertib resistance. Preclinically, we showed that onvansertib inhibited the hypoxia pathway and exhibited robust antitumor activity in combination with bevacizumab through the inhibition of angiogenesis.</p><p><strong>Conclusion: </strong>Onvansertib in combination with FOLFIRI + bevacizumab showed significant activity in the second-line treatment of patients with <i>KRAS</i>-mutant mCRC, particularly in patients with no prior bevacizumab treatment. These findings led to the evaluation of the combination in the first-line setting (ClinicalTrails.gov identifier: NCT06106308).</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"840-851"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11856007/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Axillary Surgery for Patients With Residual Isolated Tumor Cells (ypN0i+) After Neoadjuvant Systemic Therapy for Early Breast Cancer.","authors":"Elisa Agostinetto, Carmela Caballero, Michail Ignatiadis, C Florin Pop","doi":"10.1200/JCO-24-01711","DOIUrl":"10.1200/JCO-24-01711","url":null,"abstract":"<p><p><i>The Oncology Grand Rounds series is designed to place original reports published in the</i> Journal <i>into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors' suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in</i> Journal of Clinical Oncology<i>, to patients seen in their own clinical practice</i>.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"771-775"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621272","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}

{"title":"Intermittent or Continuous Panitumumab Plus Fluorouracil, Leucovorin, and Irinotecan for First-Line Treatment of <i>RAS</i> and <i>BRAF</i> Wild-Type Metastatic Colorectal Cancer: The IMPROVE Trial.","authors":"Antonio Avallone, Francesco Giuliani, Alfonso De Stefano, Giuseppe Santabarbara, Guglielmo Nasti, Vincenzo Montesarchio, Gerardo Rosati, Antonino Cassata, Silvana Leo, Carmela Romano, Emiliano Tamburini, Lucrezia Silvestro, Claudio Lotesoriere, Anna Nappi, Daniele Santini, Antonella Petrillo, Alfredo Colombo, Antonio Febbraro, Alessandra Leone, Francesco Mannavola, Maria Maddalena Laterza, Francesco Izzo, Alberto Sobrero, Paolo Delrio, Diana Giannarelli, Alfredo Budillon","doi":"10.1200/JCO.24.00979","DOIUrl":"10.1200/JCO.24.00979","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate whether intermittent treatment after an induction phase of first-line schedule of fluorouracil, leucovorin, and irinotecan (FOLFIRI) plus panitumumab (PAN) prevents or delays the onset of resistance and improves safety and compliance with treatment in patients with unresectable <i>RAS</i>/<i>BRAF</i> wild-type (wt) metastatic colorectal cancer (mCRC).</p><p><strong>Patients and methods: </strong>IMPROVE (ClinicalTrials.gov identifier: NCT04425239) was an open-label, multicenter, randomized phase II noncomparative trial. Patients with unresectable <i>RAS</i>/<i>BRAF</i> wt mCRC were randomly assigned (1:1) to receive FOLFIRI plus PAN continuously until progression (arm A) or intermittently, with treatment-free intervals (arm B) until progression on treatment, toxicity, or death. The primary end point was progression-free survival on treatment (PFSot) at 12 months. Assuming a null hypothesis of median PFSot time ≤7 months and target PFSot ≥10 months, 65 patients per arm were needed to achieve 80% power and 10% type I error, according to the binomial test.</p><p><strong>Results: </strong>Between May 2018 and June 2021, 69 patients were randomly assigned to arm A and 68 to arm B. The median number of treatment cycles was 13 in arm A and 16 in arm B. At a median follow-up of 43.2 months (IQR, 35.0-50.5), median PFSot was 11.2 and 17.5 months with 12-month PFSot rates of 45.7% and 58.5%, for arms A and B, respectively. The overall response rates were 68.1% and 61.2%, and median overall survival rates were 36.3 and 35.1 months in arms A and B, respectively. The overall rate of grade >2 skin PAN-related adverse events was 30.3% in arm A and 17.9% in arm B.</p><p><strong>Conclusion: </strong>Intermittent FOLFIRI plus PAN after the induction phase was feasible, and the primary end point was met with reduced toxicity while allowing patients more time off treatment.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"829-839"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11856000/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142692379","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Annual Versus Biennial Mammographic Screening.","authors":"Donald A Berry","doi":"10.1200/JCO-24-01902","DOIUrl":"10.1200/JCO-24-01902","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"895-896"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846836","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}

{"title":"Breast Cancer Screening Interval: Effects of Proportions and Biases on Benefits.","authors":"Philippe Autier","doi":"10.1200/JCO-24-01965","DOIUrl":"10.1200/JCO-24-01965","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"894-895"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846817","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}

{"title":"Navigating Gatekeeping Challenges in Pediatric and Young Adult Palliative Oncology and End-of-Life Research.","authors":"Prasanna Ananth, Jennifer M Snaman","doi":"10.1200/JCO-24-01944","DOIUrl":"10.1200/JCO-24-01944","url":null,"abstract":"<p><p>Participation in research offers families a sense of control and meaning in pediatric cancer care. Gatekeeping limits progress-collaboration is key. #PediatricOncology #PalliativeCare #Research #PallOnc #pedonc #hpm #hapc.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"776-779"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142576158","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}

{"title":"Reply to: \"Annual Versus Biennial Mammographic Screening\" and \"Breast Cancer Screening Interval: Effects of Proportions and Biases on Benefits\".","authors":"Margarita L Zuley, Andriy I Bandos, Stephen W Duffy, Durwin Logue, Rohit Bhargava, Priscilla F McAuliffe, Adam M Brufsky, Robert M Nishikawa","doi":"10.1200/JCO-24-02373","DOIUrl":"10.1200/JCO-24-02373","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"896-897"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11867873/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hyperthermic Intraperitoneal Chemotherapy in Platinum-Sensitive Recurrent Ovarian Cancer: A Randomized Trial on Survival Evaluation (HORSE; MITO-18).","authors":"Anna Fagotti, Barbara Costantini, Francesco Fanfani, Diana Giannarelli, Pierandrea De Iaco, Vito Chiantera, Vincenzo Mandato, Giorgio Giorda, Giovanni Aletti, Stefano Greggi, A Myriam Perrone, Vanda Salutari, Rita Trozzi, Giovanni Scambia","doi":"10.1200/JCO.24.00686","DOIUrl":"10.1200/JCO.24.00686","url":null,"abstract":"<p><strong>Purpose: </strong>To investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to secondary cytoreductive surgery (SCS) without neoadjuvant chemotherapy has a benefit on progression-free survival (PFS), as opposed to SCS alone in patients with platinum-sensitive recurrent epithelial ovarian cancer (platinum-free interval, >6 months).</p><p><strong>Methods: </strong>This was a multicenter randomized phase III study. Random assignment was performed at the time of surgery in cases with residual tumor ≤0.25 cm. HIPEC with cisplatin (CDDP) 75 mg/m² for 60 minutes at 41.5°C was administered at the end of surgery in the experimental arm. Both groups received postoperative platinum-based chemotherapy. The primary end point was PFS. The safety profile and postrecurrence survival (PRS) were the secondary end points.</p><p><strong>Results: </strong>A total of 167 patients underwent random assignment, 82 patients to SCS plus HIPEC (experimental arm) and 85 to SCS alone (control arm). The median follow-up was 83 months (IQR, 64-102). The median PFS was 23 months (95% CI, 17 to 29) in the group that underwent surgery alone and 25 months (95% CI, 18 to 32) in the group that underwent cytoreductive surgery with HIPEC. The probability of PRS at 5 years was 61.6% (95% CI, 50.8 to 72.4) in the SCS group and 75.9% (95% CI, 66.5 to 85.3) in the SCS plus HIPEC group. The incidence of postoperative adverse events of any grade was similar between the two groups.</p><p><strong>Conclusion: </strong>The addition of HIPEC to complete or nearly complete primary SCS did not confer a benefit in terms of PFS in patients with platinum-sensitive peritoneal recurrence.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"852-860"},"PeriodicalIF":42.1,"publicationDate":"2025-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142686994","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}