BMJ oncologyPub Date : 2026-04-30eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-000999
Rachael Stannard, Paul C Lambert, Therese M-L Andersson, Sam Khan, Georgios Lyratzopoulos, Elisavet Syriopoulou, Mark J Rutherford
{"title":"Estimating the impact of cancer diagnosis on life expectancy by stage at diagnosis: population-based estimates for a range of cancer sites in England.","authors":"Rachael Stannard, Paul C Lambert, Therese M-L Andersson, Sam Khan, Georgios Lyratzopoulos, Elisavet Syriopoulou, Mark J Rutherford","doi":"10.1136/bmjonc-2025-000999","DOIUrl":"https://doi.org/10.1136/bmjonc-2025-000999","url":null,"abstract":"<p><strong>Objective: </strong>Unlike survival measures, life expectancy readily illustrates the burden of cancer on society and the average impact on individuals diagnosed with cancer. Cancer stage at diagnosis is a key prognostic factor and hence it is important to obtain stage-specific life expectancy estimates. However, completeness of recording for cancer stage at diagnosis is often historically poor in cancer registries. Therefore, it can be challenging to obtain the long-term stage-specific survival estimates required for estimating stage-specific life expectancy. We provide the first stage-specific life expectancy estimates using whole population data in England.</p><p><strong>Methods and analysis: </strong>Multiple imputation was used to impute values of cancer stage at diagnosis for patients with missing stage at diagnosis information. The simultaneous application of period analysis to obtain up-to-date estimates restricts the contribution of patients with historical diagnoses and hence improves the overall completeness of stage at diagnosis information. For each of the 10 cancer sites in this study, we fit a flexible parametric excess hazard model for each cancer stage on the cumulative excess hazard scale and estimated stage-specific life expectancy using the relative survival framework.</p><p><strong>Results: </strong>The differences in stage-specific and sex-specific life expectancy were evaluated from 40 to 90 years of age. Colorectal cancer, prostate cancer and bladder cancer yield much lower estimates of life expectancy for patients diagnosed with stage IV cancer compared with stages I-III. For example, female patients diagnosed with stage IV colorectal cancer at 70 years of age have a life expectancy of 72.3 years, while those with stages I-III can expect to live beyond 82.0 years. The remaining cancer sites yield approximately equal reductions in life expectancy with each increase in stage at diagnosis from I to IV.</p><p><strong>Conclusion: </strong>We offer the first stage-specific life expectancy estimates for a range of cancer sites in England using data from the National Cancer Registration and Analysis Service, with follow-up until February 2020. Estimates of stage-specific life expectancy provide a real-world, intuitive metric to evaluate the impact of cancer stage at diagnosis on prognosis up to a lifetime horizon. Stage-specific life expectancy estimates also provide key information regarding the potential benefits of early diagnosis initiatives in terms of gains in life years.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e000999"},"PeriodicalIF":0.0,"publicationDate":"2026-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13140960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846864","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-29eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2026-001078
Filip Jansåker, Xinjun Li, Kristina Sundquist
{"title":"Testicular cancer incidence and associations with prior epididymo-orchitis or urinary tract infections: a national cohort study in Sweden, 1964-2018.","authors":"Filip Jansåker, Xinjun Li, Kristina Sundquist","doi":"10.1136/bmjonc-2026-001078","DOIUrl":"https://doi.org/10.1136/bmjonc-2026-001078","url":null,"abstract":"<p><strong>Objective: </strong>To examine the extent to which epididymo-orchitis or urinary tract infections (UTI) may precede testicular cancer (TC) in Sweden.</p><p><strong>Methods and analysis: </strong>We conducted a nationwide, open-cohort study including 8 382 433 men between 1964 and 2018. Standardised incidence ratios (SIR) with 95% CIs were calculated to compare TC incidence rates in men diagnosed with epididymo-orchitis or UTI-either in the same calendar year as TC or in preceding calendar years (mean follow-up: 6.85 years, ±8.31 SD)-with those in men without these infections. Analyses were controlled for potential confounders and a sensitivity analysis on cystitis was also conducted.</p><p><strong>Results: </strong>A total of 11 903 men were diagnosed with TC during the study period; of these, 400 (3.36%) had been diagnosed with epididymo-orchitis and 122 (1.02%) with UTI. The TC incidence rate per 100 000 person-years was 5.09 (95% CI 4.99 to 5.18) for the entire study period and increased from 2.84 (2.68 to 3.02) in 1964-1973 to 8.37 (7.99 to 8.77) in 2014-2018. Among men with epididymo-orchitis (n=89 596), TC was diagnosed in 0.45%, with an overall SIR of 6.34 (95% CI 5.73 to 7.00) in the full model. For TC diagnosed in the same calendar year as epididymo-orchitis (289 cases), the SIR was 85.97 (76.33 to 96.50). For TC diagnosed in subsequent calendar years (111 cases) the SIR was 1.86 (1.53 to 2.24), with most cases diagnosed within 1-4 calendar years of follow-up (65 cases). Among men with UTI (n=294 201), TC was diagnosed in only 0.04%, with an overall SIR of 1.74 (1.44 to 2.08). The associations were not significant for TC diagnosed 1-4 years after UTI, nor between cystitis and subsequent TC.</p><p><strong>Conclusion: </strong>The association between epididymo-orchitis and TC was strong and persisted for several years after the infection. The findings support clinicians maintaining a heightened awareness of TC in patients with epididymo-orchitis, particularly when in diagnostic doubt or if symptoms persist, and could be a foundation for more detailed clinical studies on epididymo-orchitis as a potential TC risk factor. Although a potential link between UTI and TC was identified, the absolute risk was almost negligible.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001078"},"PeriodicalIF":0.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13140954/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-29eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2026-001096
Jasmine G Hughes, Sammer Marzouk, Erick Vicent Mahatara, Ketan Tamirisa, Faraan Rahim, Helen Bulbeck, Ntuli A Kapologwe
{"title":"Integrating patient and public involvement to strengthen oncology research in sub-Saharan Africa.","authors":"Jasmine G Hughes, Sammer Marzouk, Erick Vicent Mahatara, Ketan Tamirisa, Faraan Rahim, Helen Bulbeck, Ntuli A Kapologwe","doi":"10.1136/bmjonc-2026-001096","DOIUrl":"https://doi.org/10.1136/bmjonc-2026-001096","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001096"},"PeriodicalIF":0.0,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13141009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-28eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-000966
Montserrat Garcia-Closas, Zoey Richards, Reuben Frost, Marc J Gunter, Amy Berrington de Gonzalez
{"title":"Temporal trends in behavioural risk factors for cancers with rising incidence in younger adults: an analysis of population-based data in England.","authors":"Montserrat Garcia-Closas, Zoey Richards, Reuben Frost, Marc J Gunter, Amy Berrington de Gonzalez","doi":"10.1136/bmjonc-2025-000966","DOIUrl":"https://doi.org/10.1136/bmjonc-2025-000966","url":null,"abstract":"<p><strong>Objective: </strong>To assess whether changes in behavioural risk factors could explain rising cancer incidence in younger adults in England, and to evaluate the extent to which established and suspected risk factors contribute to these trends.</p><p><strong>Methods and analysis: </strong>Cancer incidence data from national registries (2001-2019) for 22 sites in women and 21 in men identified cancers with increasing incidence in adults aged 20-49 years. Trends in smoking, alcohol, diet, body mass index (BMI) and physical inactivity were examined using national health surveys. Annual percentage changes (APCs) quantified trends by age and sex. Population attributable fractions (PAFs) estimated the proportion of cancers attributable to risk factors and disaggregated attributable from non-attributable incidence rates.</p><p><strong>Results: </strong>Eleven cancer sites (three female-specific) with established behavioural risk factors showed rising incidence in younger adults. Similar trends were observed in older adults, except for colorectal and ovarian cancer, which increased only in younger adults. For some cancers, incidence increased more rapidly in younger than older adults. PAFs for younger adults ranged from 7% to 65% depending on cancer type. All risk factors except obesity showed stable or declining prevalence. For BMI-related cancers, both BMI-attributable and BMI-non-attributable incidence increased, though more slowly for the latter. For example, BMI-attributable colorectal cancer in younger women increased from 0.9 to 1.6 per 100 000 (APC 4.3%), while non-attributable rates rose from 6.4 to 9.6 (APC 3.2%).</p><p><strong>Conclusions: </strong>Behavioural risk factors account for a substantial share of cancer burden but, apart from BMI, are unlikely to explain the rising incidence in younger adults. The present findings underscore the urgent need to investigate emerging risk factors, while strengthening prevention efforts targeting known factors across all ages.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e000966"},"PeriodicalIF":0.0,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13141096/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147846895","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-13eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2026-001129
Chao-Yang Chen, Oscar Lee
{"title":"CXCR4 in colorectal cancer: from prognostic marker to immunotherapy guide?","authors":"Chao-Yang Chen, Oscar Lee","doi":"10.1136/bmjonc-2026-001129","DOIUrl":"10.1136/bmjonc-2026-001129","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001129"},"PeriodicalIF":0.0,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13084772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147724696","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-07eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2026-001082
Jens Lehmann
{"title":"Beyond the label: patient-reported outcomes and post-approval communication in oncology.","authors":"Jens Lehmann","doi":"10.1136/bmjonc-2026-001082","DOIUrl":"https://doi.org/10.1136/bmjonc-2026-001082","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001082"},"PeriodicalIF":0.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064193/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147678780","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-07eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-000942
Saeid Shahraz, On Yee Wong, Rina Chotai, Sarah Knight, Denise Globe, Mira J Patel, Ankita Kaushik, Olalekan Lee Aiyegbusi, Melanie Calvert
{"title":"Communicating clinical trial information about cancer drug products to patients and healthcare professionals: review of patient-reported outcome messaging.","authors":"Saeid Shahraz, On Yee Wong, Rina Chotai, Sarah Knight, Denise Globe, Mira J Patel, Ankita Kaushik, Olalekan Lee Aiyegbusi, Melanie Calvert","doi":"10.1136/bmjonc-2025-000942","DOIUrl":"https://doi.org/10.1136/bmjonc-2025-000942","url":null,"abstract":"<p><strong>Objectives: </strong>Patient-reported outcomes (PROs) are essential for understanding how cancer treatments affect individuals' symptoms, daily functioning and quality of life. This study examined how PRO data from pivotal clinical trials in breast cancer (BC), gastrointestinal (GI) cancers and non-small cell lung cancer (NSCLC) are reflected in regulatory drug labels and public-facing communications such as American Society of Clinical Oncology daily news. The goal was to identify gaps in the communication of these data, particularly in formats accessible to non-technical audiences and to highlight opportunities for improvement.</p><p><strong>Methods and analysis: </strong>We conducted a targeted review of oncology drugs approved between 2014 and 2024 by the US Food and Drug Administration and the European Medicines Agency. For each product, we assessed pivotal trials for PRO endpoints and reviewed regulatory labels for PRO claims. Public-facing materials-including sponsor websites, medical society platforms and patient advocacy content-were evaluated for the presence, clarity and visibility of PRO messaging. Messaging strength was internally rated as low, medium or high.</p><p><strong>Results: </strong>Among 128 pivotal trials (28 BC, 34 GI, 66 NSCLC), 105 (82%) included PROs-84 as secondary and 40 as exploratory endpoints. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30-item (EORTC QLQ-C30) was used in 83 trials (79.0%), and EuroQol Group in 72 (68.6%). Only 10 products included PRO content in their regulatory labelling. Of 16 BC drugs, all had PRO data, but only 4 had regulatory PRO claims. Most sponsor websites lacked PRO content; only seven products across all indications included healthcare professional-facing PRO narratives and only two on patient-facing websites. No product achieved a high messaging strength rating; 53 of 64 rated products were categorised as low (limited or no PRO communication).</p><p><strong>Conclusions: </strong>Despite widespread PRO data collection, integration into labelling and public communication remains limited. While label inclusion supports compliant dissemination, some PRO findings appear in public materials without formal claims. Advancing both methodological rigour and clear regulatory guidance is essential to promote balanced, patient-relevant communication in oncology.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e000942"},"PeriodicalIF":0.0,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064142/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147678856","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-06eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-001038
Elinor Nemlander, Eliya Abedi, Jan Hasselström, Per Ljungman, Andreas Rosenblad, Axel C Carlsson
{"title":"Incident anaemia as a marker of cancer and all-cause mortality: evidence from 380 114 adults in the population-based Stockholm Early Detection of Cancer Study (STEADY-CAN) cohort.","authors":"Elinor Nemlander, Eliya Abedi, Jan Hasselström, Per Ljungman, Andreas Rosenblad, Axel C Carlsson","doi":"10.1136/bmjonc-2025-001038","DOIUrl":"10.1136/bmjonc-2025-001038","url":null,"abstract":"<p><strong>Objective: </strong>Anaemia is common in healthcare and may indicate undiagnosed cancer. Despite this, evidence regarding risk estimates informing clinical decision-making remains limited, particularly regarding haemoglobin dynamics and the role of mean corpuscular volume (MCV). We aimed to quantify the 18-month risks of incident cancer (IC) and all-cause mortality (ACM) following incident anaemia (IA), and to examine how MCV modifies these risks.</p><p><strong>Methods and analysis: </strong>Population-based, age- and sex-matched cohort study. The study used the Stockholm Early Detection of Cancer Study (STEADY-CAN), covering almost all adults residing in Stockholm County, Sweden, during 2011-2021. STEADY-CAN links laboratory tests with national registers, capturing healthcare use, diagnoses, cancer outcomes and prescribed medications.We included 190 057 adults with IA and 190 057 age- and sex-matched non-anaemic controls from the STEADY-CAN cohort. Eligible individuals were ≥18 years old, cancer-free, had ≥2 Hb measurements during 2011-2020 and a concurrent MCV value at the IA date. IA was defined as the first Hb value from 2012 onwards below 130 g/L in men or 120 g/L in women after prior normal values.Sex-stratified adjusted piecewise competing-risks multi-state Cox regression models were used, with separate HRs for IA during 0-3, 3-6, 6-12 and 12-18 months of follow-up. The main outcome measures were IC and ACM during the 18-month follow-up.</p><p><strong>Results: </strong>IC occurred in 6.2% of male and 2.8% of female IA cases, compared with 2.4% and 1.1% of controls. Corresponding ACM rates were 7.4% and 4.0% in IA cases versus 2.5% and 1.7% in controls. IA implied a 9.17-fold higher IC risk and 8.50-fold higher ACM risk among men during 0-3 months of follow-up, with 8.25- and 6.14-fold higher risks among women (all p<0.001). These risks decreased over time but were still significant for both sexes at 6-12 months of follow-up for IC and 12-18 months of follow-up for ACM. Microcytosis was linked to the highest IC risk, particularly for digestive and haematological cancers, whereas macrocytosis was more strongly associated with ACM.</p><p><strong>Conclusions: </strong>IA is a strong marker of both IC and ACM in routine care. Microcytic anaemia should prompt timely gastrointestinal evaluation, while macrocytic anaemia warrants broader assessments for comorbid conditions and systemic disease. Persistently elevated risks underscore the need for structured safety-netting and continued follow-up after IA, even without a cancer identification. Our findings highlight the value of using anaemia patterns and MCV in early risk stratification.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001038"},"PeriodicalIF":0.0,"publicationDate":"2026-04-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13064123/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147678836","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-02eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-001050
Katie Wakeham, Michelle Leech, Lucinda Morris, Jeff White, Sandra Turner
{"title":"World Radiotherapy Awareness Day: how we can make a difference.","authors":"Katie Wakeham, Michelle Leech, Lucinda Morris, Jeff White, Sandra Turner","doi":"10.1136/bmjonc-2025-001050","DOIUrl":"https://doi.org/10.1136/bmjonc-2025-001050","url":null,"abstract":"","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001050"},"PeriodicalIF":0.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13052755/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147635131","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
BMJ oncologyPub Date : 2026-04-02eCollection Date: 2026-01-01DOI: 10.1136/bmjonc-2025-001024
Oscar Corli, Lorenzo Caldirola, Francesca Galli, Valter Torri, Silvio Garattini, Eliana Rulli, Giovanni Apolone
{"title":"Analgesic efficacy in women and men with cancer pain, treated with strong opioids: are there differences?","authors":"Oscar Corli, Lorenzo Caldirola, Francesca Galli, Valter Torri, Silvio Garattini, Eliana Rulli, Giovanni Apolone","doi":"10.1136/bmjonc-2025-001024","DOIUrl":"https://doi.org/10.1136/bmjonc-2025-001024","url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate sex differences in baseline clinical characteristics, analgesic response, safety profiles and treatment variations among cancer patients initiating WHO step III opioid therapy.</p><p><strong>Methods and analysis: </strong>This post hoc analysis used data from a four-arm, multicentre, randomised, comparative, superiority phase IV trial in cancer patients with moderate-to-severe pain requiring WHO step III opioids. The study was conducted across 44 specialist palliative care centres in Italy. Overall, 498 patients were evaluated, including 277 men (55.6%) and 221 women (44.4%). Eligible participants had locally advanced or metastatic tumours and persistent moderate-to-severe pain. Patients were centrally randomised (1:1:1:1) to morphine, oxycodone, buprenorphine or fentanyl around the clock. Follow-up lasted 28 days, with assessments on days 1 day, 3 days, 7 days, 14 days, 21 days and 28 days. Physicians could adjust opioid doses, add adjuvants or switch opioids as clinically indicated. Adverse drug reactions (ADRs) were recorded. Baseline assessments included oncological history, comorbidities, Karnofsky performance status and self-reported psychological status. Pain intensity (PI) was measured on a 0-10 Numerical Rating Scale for average PI (API) and worst pain over the previous 24 hours at each visit. Analgesic response was classified per Farrar's criteria as non-responders (no improvement or worsening), poor responders (<30% PI reduction) or responders (≥30% reduction). Responders with final API ≤4 were also classified as responders per Corli's criteria; others were non-responders. Statistical analyses included χ<sup>2</sup> and Fisher's exact tests, t-tests, Mann-Whitney tests, linear mixed models and logistic regression.</p><p><strong>Results: </strong>PI did not differ significantly between sexes. However, in the fentanyl group, dose increased over time differently between sexes (sex-by-time interaction: p=0.0026). Opioid switching from buprenorphine was more often due to inadequate pain control in men, and due to uncontrollable ADRs in women. Among patients with colorectal cancer, women showed greater pain reduction of the worst pain according to Farrar's criteria (91.3% vs 61.8%, p=0.022). ADRs incidence was higher in women than in men for transdermal buprenorphine (93.2% vs 77.9%, p=0.016). Higher baseline emotional tension was negatively associated with analgesic response (OR 0.64, 95% CI 0.41 to 1.00). Other efficacy and safety outcomes were not statistically significant.</p><p><strong>Conclusions: </strong>Overall pain reduction did not differ by sex; however, men and women exhibited distinct patterns in dose escalation, opioid switching and ADR profiles. Accounting for sex differences may support more tailored and effective opioid selection in cancer pain management.</p><p><strong>Trial registration number: </strong>NCT01809106.</p>","PeriodicalId":72436,"journal":{"name":"BMJ oncology","volume":"5 1","pages":"e001024"},"PeriodicalIF":0.0,"publicationDate":"2026-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13052726/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147635371","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}