• Outcome of patients with node-positive bladder cancer treated with neoadjuvant chemotherapy followed by definitive surgery or radiotherapy.

      King, Jennifer; Wang, Xin; Kennedy, Jason; Choudhury, Ananya; The Christie NHS Foundation Trust, Manchester, UK (2018-03)
    • Outcome of patients with relapsed diffuse large B-cell lymphoma who fail second-line salvage regimens in the International CORAL study.

      Van Den Neste, E; Schmitz, N; Mounier, N; Gill, D; Linch, D; Trneny, M; Milpied, N; Radford, John A; Ketterer, N; Shpilberg, O; et al. (2015-09-14)
      Salvage chemotherapy followed by autologous stem cell transplantation (ASCT) is the standard second-line treatment for relapsed and refractory diffuse large B-cell lymphoma (DLBCL). However, the strategy is less clear in patients who require third-line treatment. Updated outcomes of 203 patients who could not proceed to scheduled ASCT in the Collaborative Trial in Relapsed Aggressive Lymphoma (CORAL) are herein reviewed. In the intent-to-treat analysis, overall response rate to third-line chemotherapy was 39%, with 27% CR or CR unconfirmed, and 12% PR. Among the 203 patients, 64 (31.5%) were eventually transplanted (ASCT 56, allogeneic SCT 8). Median overall survival (OS) of the entire population was 4.4 months. OS was significantly improved in patients with lower tertiary International Prognostic Index (IPI), patients responding to third-line treatment and patients transplanted with a 1-year OS of 41.6% compared with 16.3% for the not transplanted (P<0.0001). In multivariate analysis, IPI at relapse (hazard ratio (HR) 2.409) and transplantation (HR 0.375) independently predicted OS. Third-line salvage chemotherapy can lead to response followed by transplantation and long-term survival in DLBCL patients. However, improvement of salvage efficacy is an urgent need with new drugs.Bone Marrow Transplantation advance online publication, 14 September 2015; doi:10.1038/bmt.2015.213.
    • Outcome of radiotherapy after breast conserving surgery in screen detected breast cancers.

      Magee, Brian; Stewart, Alan L; Swindell, Ric; Christie Hospital, Manchester, UK. (1999)
      The treatment outcomes were reviewed for all the patients at this institute who underwent breast irradiation after breast conserving surgery in 1991. Of a total of 643 patients treated, 194 (30%) had presented with tumours detected by screening mammography. The breast was irradiated with a tangential pair of fields, giving a dose of 40 Gy in 15 fractions over 3 weeks in 97% of these patients. A boost was not used. With a median follow-up of 4.7 years, there was better cancer related survival in patients with screen detected cancers compared with those that were non-screen detected (94% versus 84% at 5 years; P = 0.002). The breast recurrence rate at 5 years was 1% for screen detected cancers compared with 6% for those that were non-screen detected (P = 0.01). Factors additional to screen detected status that were found to be significant for cancer survival were pathological stage (P = 0.03) and histological grade (P = 0.01). In a Cox multivariate analysis, only two factors were significant for breast recurrence: screen detected status (P = 0.023) and histological grade (P = 0.016). This study suggests that breast irradiation with 40 Gy given over 3 weeks after breast conserving surgery for screen detected breast cancer gives a high level of local control out to 5 years.
    • Outcome of second-line chemotherapy for biliary tract cancer.

      Bridgewater, J; Palmer, D; Cunningham, D; Iveson, T; Gillmore, R; Waters, J; Harrison, M; Wasan, H; Corrie, P; Valle, Juan W; et al. (2013-04)
    • Outcome of solitary plasmacytoma.

      Ibrahim, Ehab; Harris, Maggie A; The Christie NHS Foundation Trust, Manchester, UK (2016)
    • Outcome of Stage IV completely necrotic wilms tumour and local stage III treated according to the SIOP 2001 protocol

      Dávila Fajardo, R.; Furtwängler, R.; van Grotel, M.; van Tinteren, H.; Pasqualini, C.; Pritchard-Jones, K.; Al-Saadi, R.; de Camargo, B.; Ramírez Villar, G. L.; Graf, N.; et al. (2021)
      Objective: Wilms tumour (WT) patients with a localised completely necrotic nephroblastoma after preoperative chemotherapy are a favourable outcome group. Since the introduction of the SIOP 2001 protocol, the SIOP- Renal Tumour Study Group (SIOP-RTSG) has omitted radiotherapy for such patients with low-risk, local stage III in an attempt to reduce treatment burden. However, for metastatic patients with local stage III, completely necrotic WT, the recommendations led to ambiguous use. The purpose of this descriptive study is to demonstrate the outcomes of patients with metastatic, completely necrotic and local stage III WT in relation to the application of radiotherapy or not. Methods and materials: all metastatic patients with local stage III, completely necrotic WT after 6 weeks of preoperative chemotherapy who were registered in the SIOP 2001 study were included in this analysis. The pattern of recurrence according to the usage of radiation treatment and 5 year event-free survival (EFS) and overall survival (OS) was analysed. Results: seven hundred and three metastatic WT patients were registered in the SIOP 2001 database. Of them, 47 patients had a completely necrotic, local stage III WT: 45 lung metastases (11 combined localisations), 1 liver/peritoneal, and 1 tumour thrombus in the renal vein and the inferior vena cava with bilateral pulmonary arterial embolism. Abdominal radiotherapy was administered in 29 patients (62%; 29 flank/abdominal irradiation and 9 combined with lung irradiation). Eighteen patients did not receive radiotherapy. Median follow-up was 6.6 years (range 1-151 months). Two of the 47 patients (4%) developed disease recurrence in the lung (one combined with abdominal relapse) and eventually died of the disease. Both patients had received abdominal radiotherapy, one of them combined with lung irradiation. Five-year EFS and OS were 95% and 95%, respectively. Conclusions: the outcome of patients with stage IV, local stage III, completely necrotic Wilms tumours is excellent. Our results suggest that abdominal irradiation in this patient category may not be of added value in first-line treatment, consistent with the current recommendation in the SIOP-RTSG 2016 UMBRELLA protocol.
    • Outcome of stage IV totally necrotic Wilms tumour and local stage III treated according to the SIOP-2001 protocol

      Fajardo, R. D.; Furtwangler, R.; Van Tinteren, H.; Pasqualini, C.; Pritchard-Jones, K.; Bergeron, C.; De Camargo, B.; Villar, G. L. R.; Van den Heuvel-Eibrink, M. M.; Graf, N.; et al. (2020)
      Background and Aims: Paediatric patients with a metastatic renal tumour and totally necrotic nephroblastoma or Wilms tumour (TN- WT) after preoperative chemotherapy have a very good outcome. In order to reduce treatment burden, SIOP-RTSG has abolished radiotherapy for metastatic patients with low-risk stage III since the introduction of the SIOP-2001 protocol. The purpose of this descriptive study is to demonstrate outcome of patients with stage IV, TN, local stage III WT, treated according to the SIOP-2001 protocol. Methods: All metastatic patients with local stage III, TN-WT after 6 weeks of preoperative chemotherapy, registered in the SIOP-2001 study were included in this analysis. The pattern of recurrence accord- ing to applied radiation treatment and 5-year loco-regional control (LRC), event-free survival (EFS) and overall survival (OS) were anal- ysed. Results: Of the 703 metastatic WT patients registered in the SIOP- 2001 protocol, 48 patients had a TN, local stage III WT (46 lung metastasis (12 combined with other localization), 1 liver/abdomen and 1 other). Adjuvant abdominal radiotherapy was administered in 27 patients (56%) (27 flank/abdominal irradiation, 8 combined with lung irradiation). Twenty-one patients were not irradiated. Median follow-up was 82 months (range 1-151 months). Two of the 48 patients (4%) developed disease recurrence (both lung, one com- bined with abdominal relapse) and eventually died. Both patients had received abdominal radiotherapy, 1 of them combined with lung irradiation. None of the patients treated without radiother- apy relapsed. Five-year LRC, EFS and OS were 98%, 95% and 95%, respectively. Conclusions: Outcome of patients with stage IV and locally stage III, totally necrotic Wilms tumours seems to be excellent. Our results suggest that irradiation in this patient category does not have any added value in first-line treatment, as recommended in the SIOP RTSG- UMBRELLA protocol.
    • The outcome of surgery for acromegaly: the need for a specialist pituitary surgeon for all types of growth hormone (GH) secreting adenoma.

      Lissett, Catherine A; Peacey, Steven R; Laing, I; Tetlow, L; Davis, Julian R E; Shalet, Stephen M; Department of Endocrinology, Christie Hospital, Manchester, UK. (1998-11)
      OBJECTIVE: Acromegaly is associated with reduced life expectancy, while therapeutic 'cure' (defined by achievement of GH levels < 5 mU/l) is associated with normalization of life expectancy. Surgery remains the treatment of choice but in those in whom operative 'cure' is not achieved, radiotherapy and/or medical treatment are valuable treatment modalities. The chance of subsequent 'cure' with radiotherapy or somatostatin analogue therapy is increased if the post-operative GH level is reduced below 30 mU/l. Using strict criteria for cure and a single dedicated pituitary surgeon, two large European studies reported 'cure' rates of 42% and 56%. In the Manchester region, surgery for these patients has been performed by a number of neurosurgeons, with no specific designated pituitary surgeon dominating the picture. We wished to examine the impact of this surgical strategy on cure rates and the incidence of a post-operative GH level below 30 mU/l. DESIGN: We reviewed the GH results between 1974 and 1997 for every acromegalic who had been referred to the endocrine departments of the two Manchester hospitals responsible for the majority of pituitary disease referrals in Manchester and who had been subsequently referred for pituitary surgery. PATIENTS AND MEASUREMENTS: Seventy-three (33 male) patients had had GH status assessed before and after surgery by an OGTT or GH profile. The patients were aged between 19 and 70 (mean 43) years at surgery. Seventy-one underwent transsphenoidal and 2 transfrontal surgery. Nine surgeons performed operations. RESULTS: Eighteen (24.7%) had microadenomas and 51 (69.9%) macroadenomas. In 4 patients (5.5%) insufficient data were available to size the adenoma. 17.8% of patients were cured by surgery, 38.8% with microadenomas and 11.8% with macroadenomas. In addition, of 52 patients whose GH levels were > 30 mU/l before surgery, only 27 (51.9%) had GH levels below 30 mU/l post-operatively (81.8% of microadenomas, 43.2% of macroadenomas). CONCLUSION: In comparison with other series, the cure rate in this study is significantly lower. The success in reducing GH levels below 30 mU/l post-operatively is difficult to compare with previously published studies, as few groups have analysed their data in this manner. Nonetheless, of our acromegalic patients with a pretreatment GH level in excess of 30 mU/l, nearly 50% have similar GH status postoperatively, thereby rendering them less amenable to cure by alternative therapeutic modalities. This highlights the importance of a specialist pituitary surgeon, not only for GH secreting microadenomas but also for GH secreting macroadenomas. If these patients are not 'cured', the cost of continuing therapy becomes a significant burden on health-care costs. In addition, if the postoperative GH levels remain above 30 mU/l the chances of achieving adequate control of GH levels are greatly reduced, thereby increasing mortality rates as well as morbidity in these patients.
    • Outcome of weekly carboplatin-paclitaxel-based definitive chemoradiation in oesophageal cancer in patients not considered to be suitable for platinum-fluoropyrimidine-based treatment: a multicentre, retrospective review

      Owens, R; Cox, C; Gomberg, S; Pan, Shermaine; Radhakrishna, Ganesh; Parikh, S; Goody, R; Hingorani, M; Prince, S; Bird, T; et al. (2019)
      AIMS: Although cisplatin-fluoropyrimidine-based definitive chemoradiotherapy (dCRT) is a standard of care for oesophageal cancer, toxicity is significant and limits its use in elderly and frail patients. Weekly carboplatin-paclitaxel-based dCRT provides a viable alternative, although prospective data are lacking in the dCRT setting. Here we report the results of a national, multicentre retrospective review of outcome in patients treated with weekly carboplatin-paclitaxel-based dCRT. MATERIALS AND METHODS: In this multicentre retrospective study of nine radiotherapy centres across the UK we evaluated the outcome of patients who had non-metastatic, histologically confirmed carcinoma of the oesophagus (adenocarcinoma, squamous cell or undifferentiated; World Health Organization performance status 0-2; stage I-III disease) and had been selected to receive weekly carboplatin-paclitaxel-based dCRT as they were considered not suitable for cisplatin-fluoropyrimidine-based dCRT. dCRT consisted of carboplatin AUC 2 and paclitaxel 50 mg/m2 (days 1, 8, 15, 22, 29) and the recommended radiation dose was 50 Gy in 25 daily fractions. We assessed overall survival, progression-free survival (PFS; overall, local and distant), proportion of patients who were failure free at the response assessment (12 weeks after dCRT), treatment compliance and toxicity. RESULTS: In total, 214 patients from nine UK centres were treated between 15 February 2013 and 19 March 2019: 39.7% of patients were ?75 years; 18.7% ? 80 years. Indications for weekly carboplatin-paclitaxel-based dCRT were comorbidities (47.2%), clinician choice (36.4%) and poor tolerance/progression on cisplatin-fluoropyrimidine induction chemotherapy (15.8%). The median overall survival was 24.28 months (95% confidence interval 20.07-30.09) and the median PFS was 16.33 months (95% confidence interval 14.29-20.96). Following treatment, 69.1% (96/139) had a combined complete response on endoscopy with non-progression (complete response/partial response/stable disease) on imaging. The 1- and 2-year overall survival rates for this patient group were 81.9% (95% confidence interval 75.6-86.8%) and 50.6% (95% confidence interval 40.5-60.0%), respectively. Thirty-three per cent (n = 70) of patients experienced at least one grade 3 + acute toxicity (grade 3/4 haematological: 10%; grade 3/4 non-haematological: 32%) and there were no treatment-related deaths. 86.9% of patients completed at least four cycles of concomitant weekly carboplatin-paclitaxel-based chemotherapy and planned radiotherapy was completed in 97.7% (209/214). CONCLUSION: Weekly carboplatin-paclitaxel-based CRT seems to be well tolerated in elderly patients and in those with comorbidities, where cisplatin-fluoropyrimidine-based dCRT is contraindicated. Survival outcomes are comparable with cisplatin-fluoropyrimidine-based dCRT.
    • Outcomes after multiple lines of chemotherapy for platinum-resistant epithelial cancers of the ovary, peritoneum, and fallopian tube.

      Griffiths, Richard W; Zee, Ying-Kiat; Evans, Saran; Mitchell, Claire L; Kumaran, Gireesh C; Welch, Richard; Jayson, Gordon C; Clamp, Andrew R; Hasan, Jurjees; Departments of *Medical Oncology, and †Clinical Oncology, The Christie NHS Foundation Trust; and ‡School of Cancer and Enabling Science, University of Manchester, Manchester, UK. (2011-01)
      : Platinum-resistant and refractory cancers of the ovary, fallopian tube, and peritoneum have a poor prognosis, yet in some cases, they can respond to multiple lines of chemotherapy. Uncertainty remains over optimal drug choice and when therapeutic focus should be switched from active therapy to supportive care.
    • Outcomes and prognostic factors in angioimmunoblastic T cell lymphoma: final report from the International TCell Project

      Advani, R.; Skrypets, T.; Civallero, M.; Spinner, M. A.; Manni, M.; Kim, W.; Shustov, A.; Horwitz, S. M.; Hitz, F.; Cabrera, M. E.; et al. (2021)
      Angioimmunoblastic T-cell lymphoma (AITL) is a unique subtype of peripheral T-cell lymphoma (PTCL) with distinct clinicopathologic features and poor prognosis. We performed a subset analysis of 282 patients with AITL enrolled between 2006 and 2018 in the international prospective T-cell Project (NCT01142674). The primary and secondary endpoints were 5-year overall survival (OS) and progression-free survival (PFS), respectively. We analyzed the prognostic impact of clinical covariates and progression of disease within 24 months (POD24) and developed a novel prognostic score. The median age was 64 years, and 90% of patients had advanced stage disease. Eighty-one percent received anthracycline-based regimens and 13% underwent consolidative autologous stem cell transplant (ASCT) in first complete remission (CR1). Five-year OS and PFS estimates were 44% and 32%, respectively, with improved outcomes for patients who underwent ASCT in CR1. In multivariate analysis, age ³60 years, ECOG performance status >2, elevated C-reactive protein, and elevated β2 microglobulin were associated with inferior outcomes. A novel prognostic score (AITL score) combining these factors defined low, intermediate, and high-risk subgroups with 5-year OS estimates of 63%, 54%, and 21%, respectively, with greater discriminant power than established prognostic indices. Finally, POD24 was a powerful prognostic factor with 5-year OS of 63% for patients without POD24 compared to only 6% for patients with POD24 (p<0.0001). These data will require validation in a prospective cohort of homogeneously treated patients. Optimal treatment of AITL continues to be an unmet need and novel therapeutic approaches are required.
    • Outcomes and prognostic factors in angioimmunoblastic T-cell lymphoma: final report from the international T-cell Project

      Advani, R. H.; Skrypets, T.; Civallero, M.; Spinner, M. A.; Manni, M.; Kim, W. S.; Shustov, A. R.; Horwitz, S. M.; Hitz, F.; Cabrera, M. E.; et al. (2021)
      Angioimmunoblastic T-cell lymphoma (AITL) is a unique subtype of peripheral T-cell lymphoma (PTCL) with distinct clinicopathologic features and poor prognosis. We performed a subset analysis of 282 patients with AITL enrolled between 2006 and 2018 in the international prospective T-cell Project (NCT01142674). The primary and secondary end points were 5-year overall survival (OS) and progression-free survival (PFS), respectively. We analyzed the prognostic impact of clinical covariates and progression of disease within 24 months (POD24) and developed a novel prognostic score. The median age was 64 years, and 90% of patients had advanced-stage disease. Eighty-one percent received anthracycline-based regimens, and 13% underwent consolidative autologous stem cell transplant (ASCT) in first complete remission (CR1). Five-year OS and PFS estimates were 44% and 32%, respectively, with improved outcomes for patients who underwent ASCT in CR1. In multivariate analysis, age ≥60 years, Eastern Cooperative Oncology Group performance status >2, elevated C-reactive protein, and elevated β2 microglobulin were associated with inferior outcomes. A novel prognostic score (AITL score) combining these factors defined low-, intermediate-, and high-risk subgroups with 5-year OS estimates of 63%, 54%, and 21%, respectively, with greater discriminant power than established prognostic indices. Finally, POD24 was a powerful prognostic factor with 5-year OS of 63% for patients without POD24 compared with only 6% for patients with POD24 (P < .0001). These data will require validation in a prospective cohort of homogeneously treated patients. Optimal treatment of AITL continues to be an unmet need, and novel therapeutic approaches are required.
    • Outcomes and tolerability of second line treatment for non small cell lung cancer (NSCLC)

      Salih, Zena; Conway, A M; Bayman, Neil A; Blackhall, Fiona H; Califano, Raffaele; Harris, Maggie A; Lee, Lip W; Sheikh, Hamid Y; Taylor, Paul; Summers, Yvonne J; et al. (2016)
    • Outcomes following front-line chemotherapy in peripheral T-cell lymphoma: 10-year experience at The Royal Marsden and The Christie Hospital.

      Gleeson, M; Peckitt, C; Cunningham, D; Gibb, Adam; Hawkes, E; Back, Morgan; Yasar, Binnaz; Foley, Kate; Lee, Rebecca J; Dash, Joanna; et al. (2017-11-09)
      We evaluated the outcomes for patients with peripheral T-cell lymphoma (PTCL) undergoing front-line chemotherapy at our institutions between 2002 and 2012. One hundred and fifty-six patients were eligible, comprising PTCL not otherwise specified (NOS) (n = 50, 32.0%), angioimmunoblastic T-cell lymphoma (AITL) (n = 44, 28.2%), anaplastic large-cell lymphoma (ALCL) ALK negative (n = 23, 14.7%), ALCL ALK positive (n = 16, 10.3%), and other (n = 23, 14.7%). Most patients received CHOP (66.0%) and 13.0% received an autologous hematopoietic progenitor cell transplant (HPCT). With a median follow-up of 63.4 months, 5-year overall survival (OS) and progression-free survival (PFS) was 38.8% and 19.8% respectively. Independent risk factors for inferior OS were age >60 years, International Prognostic Index (IPI) ≥ 2 and lack of complete response to induction. When responding patients were compared by receipt of an autologous HPCT versus not, HPCT was associated with improved PFS (p = .001) and OS (p = .046) and remained significant for PFS in multivariate analysis suggesting a possible therapeutic benefit.
    • Outcomes following hip fracture surgery: a 2-year prospective study.

      Burns, A; Younger, Jane; Morris, J; Baldwin, R; Tarrier, N; Pendleton, N; Cohen, P; Horan, M; Banerjee, S; Faculty of Medical and Human Sciences, Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester, England. Electronic address: alistair.burns@manchester.ac.uk. (2014-08)
      To describe the health outcomes in older people following hip fracture surgery.
    • Outcomes Following Hip Fracture Surgery: A 2-Year Prospective Study.

      Burns, A; Younger, Jane; Morris, J; Baldwin, R; Tarrier, N; Pendleton, N; Cohen, P; Horan, M; Banerjee, S; From the Faculty of Medical and Human Sciences, Institute of Brain, Behaviour and Mental Health, University of Manchester, Manchester (AB, RB, MH, NP); (2012-11-22)
      OBJECTIVES:: To describe the health outcomes in older people following hip fracture surgery. DESIGN, SETTING, AND PARTICIPANTS:: A naturalistic prospective study of people who had undergone hip fracture surgery undertaken in three specialist inpatient orthopaedic units in Manchester, England, with follow-up for 2 years in primary care. One hundred forty-two people, age 60 and older who had undergone hip fracture surgery of whom 74 were interviewed at follow-up. MEASUREMENTS:: Assessment of mood (using the Geriatric Depression Scale and Hospital Anxiety and Depression Scale), cognitive function (Mini-Mental State Examination), pain (Wong-Baker and McGill scales), tests of function (Up and Go Test, Gait Test and Functional Reach), and Sickness Impact Profile. RESULTS:: Twenty-six percent of the original group had died by the time of the 2-year follow-up and associated with increasing age, poorer mobility, and higher levels of support. Sixteen percent of the group were found to be depressed, the only robust predictor of this being depression at entry to the study. There was a consistency in the presence or absence of depressive symptoms over the duration of the study. Forty-nine percent were able to walk independently at 2 years. CONCLUSION:: The presence of depressive symptoms is associated with poor outcomes at 2 years. Few people recover from, or develop, depression over 2 years.
    • Outcomes following stereotactic radiosurgery for syncronous brain metastases in non-small cell lung cancer

      Wilson, F; Yousif, S; Li, Y; Bayman, Neil A; Chan, Clara; Cobben, David; Colaco, Rovel J; Coote, Joanna H; Faivre-Finn, Corinne; Gattamaneni, Rao; et al. (2019)
    • Outcomes for patients in the pembrolizumab plus axitinib arm with advanced renal cell carcinoma (RCC) who completed two years of treatment in the phase III KEYNOTE-426 study

      Plimack, E. R.; Powles, T.; Bedke, J.; Pouliot, F.; Stus, V.; Waddell, Thomas K; Gafanov, R.; Nosov, D.; Alekseev, B.; McDermott, R. S.; et al. (2021)
      Background: In the randomized, open-label, phase III KEYNOTE-426 study (NCT02853331), pembrolizumab + axitinib significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) versus sunitinib as first-line therapy for advanced RCC. Per protocol, patients could discontinue pembrolizumab or axitinib and continue the other agent. Pembrolizumab was stopped for all patients at 2 years. Axitinib could be continued until progression or toxicity. This exploratory subgroup analysis of KEYNOTE-426 describes outcomes of patients who completed 2 years of pembrolizumab. Methods: Patients included in KEYNOTE-426 were treatment naive, with clear cell RCC, KPS ≥70%, and measurable disease (RECIST v1.1). Patients were randomly assigned 1:1 to receive pembrolizumab 200 mg intravenously every 3 weeks for up to 35 doses + axitinib 5 mg orally twice daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off) until progression, toxicity, or withdrawal. Primary end points of the original analysis were OS and PFS. Key secondary end points were ORR and safety. Results: Of 432 patients treated with pembrolizumab + axitinib, 129 (29.9%) completed 2 years of study therapy. Median (range) age of these patients was 61 (36-82) years, and 72.1% were male; 42 (32.6%) and 87 (67.4%) patients had International mRCC Database Consortium favorable and intermediate/poor risk, respectively, consistent with the intention-to-treat population (31.9% vs 68.1%). Median (range) follow-up (time from randomization to data cutoff) was 31.1 (24.0-37.7) months. For patients who completed 2 years of study therapy, the OS rates at 36 months was 93.8% (95% CI, 85.5%-97.4%). The PFS rates at 24 and 36 months were 72.7% (95% CI, 64.0%-79.7%) and 57.7% (95% CI, 46.3%-67.5%), respectively. The ORR was 85.3%, and the CR rate was 14.0%. 59.7% of patients experienced grade 3-5 treatment-related adverse events and 8.5% experienced grade 3-5 immune-mediated adverse events. Conclusions: In this exploratory analysis, a significant proportion of patients in the pembrolizumab + axitinib arm completed 2 years of pembrolizumab with ongoing clinical benefit