Early stage ovarian cancer: a randomized clinical trial comparing whole abdominal radiotherapy, melphalan, and intraperitoneal chromic phosphate: a National Cancer Institute of Canada Clinical Trials Group report.

1988 ◽  
Vol 6 (8) ◽  
pp. 1254-1263 ◽  
Author(s):  
D Klaassen ◽  
W Shelley ◽  
A Starreveld ◽  
M Kirk ◽  
D Boyes ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Residual Disease ◽  
Early Stage ◽  
Performance Status ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Target Volume ◽  
Significant Difference ◽  
Abdominal Radiotherapy ◽  
Multifactor Analysis

Two hundred fifty-seven eligible patients with stage I, IIA "high risk" ovarian carcinoma and IIB, IIIO (disease confined to pelvis), were randomized to either total abdominal radiotherapy (arm A) 2,250 rad in 20 fractions (107 patients), melphalan (arm B) 8 mg/m2/d X 4 every 4 weeks X 18 courses (106 patients), or intraperitoneal chromic phosphate (arm C) 10 to 20 mCi (44 patients). All patients were initially treated with pelvic radiotherapy; arm A, 2,250 rad in ten fractions; and arms B and C, 4,500 rad in 20 fractions. Entry to arm C was discontinued early because of toxicity. In a multifactor analysis using proportional hazards models, no significant difference in survival was observed although there was a marginally significant difference in disease-free survival (P = .015) with arm B being superior to arm A. Stage (P less than .0001), grade (P less than .0001), and histology (P less than .008) were predictors of survival in the multifactor analysis. Performance status, age, and residual disease were significant predictors in the single factor analysis but were not predictive when correction was made for the effects of stage, grade, and histology. Five-year survival rates are 62% for arm A, 61% for arm B, and 66% for arm C. Median duration of follow-up is 8 years. Long-term complications of radiotherapy were seen in 19 patients on arm A, 11 on arm B, and 11 on arm C. Four patients who had received melphalan developed either a myelodysplastic syndrome or acute leukemia. Violations in covering the whole abdominal target volume were correlated with survival.

Comparison of chemoradiotherapy (CRT) using carboplatin/paclitaxel (CP) versus cisplatin/5-FU (CF) for esophageal or gastroesophageal junctional (GEJ) cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 4053-4053 ◽  
Author(s):  
Hao-Wen Sim ◽  
Bryan Anthony Chan ◽  
Akina Natori ◽  
Charles Henry Lim ◽  
Di Maria Jiang ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Performance Status ◽  
Disease Free Survival ◽  
Standard Of Care ◽  
Cox Proportional Hazards ◽  
Definitive Treatment ◽  
Current Standard ◽  
Standard Regimen ◽  
Trimodality Therapy ◽  
Significant Difference

4053 Background: For resectable esophageal or GEJ cancer, trimodality therapy improves survival compared to surgery alone and represents the current standard of care. The optimal CRT regimen for neoadjuvant or definitive treatment of locoregional esophageal or GEJ cancer remains uncertain. Methods: A retrospective comparison of CF and CP for locoregional esophageal or GEJ cancer (2011-2015) was performed. Overall survival (OS) and disease-free survival (DFS) were assessed using multivariable Cox proportional hazards regression, controlling for age, performance status and Charlson comorbidity index. Results: 101 patients (pts) were identified (61 CF, 40 CP). 75% were male. Median age was 62 years (range 30-84). Primary sites were esophageal (52%, with 65% squamous histology) and GEJ (48%). Surgery was undertaken in 34 (56%) CF and 27 (68%) CP pts. Median follow-up was 43 months. Overall, there was a non-significant trend for improved OS with CF compared to CP (HR 0.61, 95% CI 0.33-1.14, p = 0.12). In the subgroup having surgery (N = 61), we found no significant difference in OS (HR 0.99, 95% CI 0.39-2.55, p = 0.99). In the subgroup without surgery (N = 40), CF was significantly superior to CP (HR 0.21, 95% CI 0.08-0.53, p < 0.001). Comparing only pts in this subgroup who received equitable radiation doses (N = 33), CF was still significantly superior to CP (HR 0.09, 95% CI 0.03-0.32, p < 0.001). OS was similar by histology (adenocarcinoma/squamous) in all-comers (p = 0.54), and in CF (p = 0.90) and CP subgroups (p = 0.63). DFS results corresponded with OS. There was a non-significant numerical difference in pCR rates between CF (31%) and CP (18%) (p = 0.35), which were lower than previously reported. Conclusions: Survival is similar for CF and CP CRT regimens in pts undergoing trimodality therapy, but for those who do not proceed to surgery, it appears that CF is more effective than CP. Clinicians may prefer CP for surgical candidates given its favourable toxicity profile. However, when treating with definitive CRT, CF may be preferable to CP as a standard regimen.

scholarly journals Epithelial Borderline Ovarian Tumor: Clinicopathological Features, Outcome and Prognostic Factors

2018 ◽  
Vol 3 (4) ◽  
pp. 75
Author(s):  
Amornrat Temtanakitpaisan ◽  
Pilaiwan Kleebkaow ◽  
Apiwat Aue-aungkul
Keyword(s):  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Residual Disease ◽  
Early Stage ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Borderline Ovarian Tumor ◽  
Free Survival ◽  
Pathologic Features ◽  
Disease Free

Objective: To evaluate clinic-pathological characteristics, treatment outcomes, factors affecting survival in patients with borderline ovarian tumors (BOTs).Methods and Objective: Medical records of patients with BOTs who had been treated at Srinagarind Hospital from 2001 to 2016 were reviewed. Abstracted data included baseline characteristics, clinic-pathologic features, disease-free survival (DFS), and overall survival (OS). Results: Fifty-two patients with BOTs were included in the study.The mean age+ SD was 41.15+ 15.34 years. Most patients were premenopausal and the most common presenting symptom was adnexal mass. Most patients were in the early stage (90.4%). Thirty-two patients underwent radical surgery (61.5%). Twenty-one patients (40.3%) underwent lymphadenectomy. An appendectomy was performed in 19 (36.5 %) cases. The median follow-up period was 67.5 months (range, 7 to 180 months). The 5-year and 10-year overall survival rates for all stages were 90% and 85%, respectively. The 5-year and 10-year disease-free survival rates for all stages was 87% and 87%, respectively. Seven (13.5 %) patients had the recurrence. Absent residual disease (HR = 0.33; 95 %CI 0.11 – 0.96) and receiving postoperative adjuvant chemotherapy (HR = 0.22; 95 %CI 0.08 – 0.65) were associated factors for DFS. Conclusion: The majority of patients with BOTs presented at the young age and early stage. Residual lesion and adjuvant chemotherapy are significant factors predicting DFS.

Does presence of chronic obstructive pulmonary disease (COPD) influence clinical behavior in patients with early-stage non-small cell lung cancer (ESNSCLC)?

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e18530-e18530
Author(s):  
Satomi Yamamoto ◽  
Tomoya Kawaguchi ◽  
Taro Tamura ◽  
Kazuhiro Asami ◽  
Kyoichi Okishio ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Early Stage ◽  
Smoking Status ◽  
Performance Status ◽  
Disease Free Survival ◽  
Lymphatic Invasion ◽  
Stage I ◽  
Chronic Obstructive ◽  
Wild Type ◽  
Significant Difference

e18530 Background: CDPD and lung cancer sometimes occurs simultaneously. COPD has been recognized as an inflammatory disease and may potentially affect biology of the accompanying tumor. It is not fully understood whether presence of CDPD influences clinical characteristics, pathological findings and/or clinical outcomes in patients with ESNSCLC. Methods: Retrospective and consecutive data were collected from the medical records of patients who underwent surgical resections at Kinki-chuo Chest Medical Center, Japan, between January 2009 and December 2010. CDPD status was classified as absence of COPD, stage I and II COPD based on the criteria of Global Initiative for Chronic Obstructive Lung Disease (GOLD). Histology, vascular / lymphatic invasion and the status of epidermal growth factor receptor (EGFR) were determined using the surgical materials. Results: A total of 319 cases was included with median age of 67 (range, 36 - 89). There were 81 cases of relapse and 40 cases of death during the median follow up of 28 months (11 days to 49 months). In the subgroup of non-COPD, stage I and II COPD, the median age, the number of case in gender (male/female), performance status (PS, 0/1), histology (squamous cell carcinoma [SQ] /non SQ), smoking status (never/ever), and EGFR status (wild type/mutant) were 67, 72, 72 (p<0.001) and 105/110, 48/12, 38/6 (p<0.001) and 170/40, 53/7, 27/14 (p=0.029) and 31/184, 12/48, 14/28 (p<0.001) and 89/122, 7/53, 2/39 (p=0.002) and 47/37, 21/3, 9/3 (p=0.013), respectively. No significant difference was observed in disease-free survival (DFS, log-rank p=0.411) and overall survival (OS, log-rank p=0.127) between the patients with and without COPD. In multivariate analysis adjusted for age, gender, PS, histology, smoking status, pathological stage, vascular / lymphatic invasion and EGFR status, presence of COPD did not affect DFS (HR=1.457, p = 0.279) nor OS (HR=0.993, p = 0.990).Conclusions: Although COPD was significantly associated with the elderly, male gender, presence of symptoms, SQ histology, ever smoking, and wild type EGFR, it did not add values of prognostic factors in patients with ESNSCLC.

scholarly journals Stereotactic body radiotherapy (SBRT) or surgery in early stage (I & II) non small cell lung cancer (NSCLC).

2019 ◽  
Vol 5 (suppl) ◽  
pp. 99-99
Author(s):  
Hirsh Koyi ◽  
Kameran Daham ◽  
Mamdoh Al-Ameri ◽  
Eva Branden
Keyword(s):  
Overall Survival ◽  
Median Overall Survival ◽  
Early Stage ◽  
Performance Status ◽  
Survival Rates ◽  
Stage I ◽  
University Hospital ◽  
Surgery Group ◽  
Significant Difference ◽  
The Difference

99 Background: For patients with NSCLC clinical stages I and II disease with no medical contraindications, surgery is treatment of choice showing 5-year survival rates of about 60–80% for stage I and 40–50% for stage II, respectively. However, for patients who are medically or technically unfit for surgery and for patients refusing surgery, SBRT is an alternative with local control rates > 90% at 3 years. Methods: Medical journals in all patients with stage I or II NSCLC who were underwent surgery and treated with SBRT at the Department of oncology or thoracic surgery, Karolinska University Hospital, Sweden from 2003 to 2010 were retrospectively reviewed. Results: In all, 267 (74.8%) underwent surgery and 90 (25.2%) were treated with SBRT. Mean, median and range of age among the surgery group was 69.2, 70.0 and 41-85 years, while in the SBRT group, these figures were 77.6, 79.0 and 52-90 years. The difference in age between the groups was significant (p < 0.001).There were significantly more comorbidites in the SBRT group. Among the surgery group, 90.2% were smokers or former smokers. The figures for SBRT group was 91.1%. The difference in smoking habits between the groups was not significant (p < 0.713). There was a significant difference in performance status (PS) between the groups (p < 0.001) with with PS 0-1 in 99.3% in the surgery group compared with 66.7% in the SBRT group. There was a significant difference in lung function with median FEV1 2.11 liter in surgery group compared to 1.3 in the SBRT group. The figures for median FEV1% was 85.0% respectively 57.0%. The median overall survival was 7.7 years for the surgery group and 3.72 years for the SBRT group (p < 0.001). Five years survival was 65.5% in the surgery group and 31.6% in the SBRT group (p < 0.001). Conclusions: The much worse median overall survival in the SBRT group can be explained by the selection of patients, but still, a median survival for nearly 4 years in an elderly group with so many comorbidities and a poor PS indicates that SBRT has been of value.

Prognostic impact of high stromal tumor-infiltrating lymphocytes (sTIL) in the absence of pathologic complete response (pCR) to neoadjuvant therapy (NAT) in early stage triple negative breast cancer (TNBC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 583-583
Author(s):  
Nour Abuhadra ◽  
Ryan Sun ◽  
Jennifer Keating Litton ◽  
Gaiane M Rauch ◽  
Alastair Mark Thompson ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Early Stage ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Tumor Infiltrating Lymphocytes ◽  
Distant Metastases ◽  
Complete Response ◽  
Cox Proportional Hazards ◽  
Prognostic Impact ◽  
Significant Difference

583 Background: Pathologic complete response is an excellent surrogate for disease-free survival (DFS) and overall survival (OS) in TNBC. High sTIL is associated with improved pCR rates in TNBC. Recent data suggest that high sTIL is also associated with improved outcomes in patients who received no chemotherapy for early stage TNBC (Park, Annals of Oncology, 2019). Thus, we hypothesized that high sTIL may have prognostic impact in patients who do not achieve pCR to NAT. Methods: Pretreatment core biopsies from 182 patients with early-stage TNBC enrolled on the ARTEMIS trial (NCT02276443) were evaluated for sTIL by H&E. Patients were stratified according to sTIL (low < 30%, and high > 30%) and pCR (patients with pCR vs. no pCR). The primary outcome measure was DFS, defined from the date of diagnosis to the first local recurrence, distant metastases or death. Cox proportional hazards regression model was used. During follow-up 33 events for DFS were observed. Results: Among subjects who achieve pCR, DFS was excellent regardless of sTIL status and significantly better than those without pCR (p < 0.05). However, patients with high sTIL and no pCR demonstrated significantly worse DFS compared to all subjects having pCR (HR 0.18, 95% CI 0.04-0.76, p = 0.02). Additionally, we did not find a significant difference between high and low sTIL patients who did not achieve pCR. Conclusions: In early TNBC receiving NAT, for patients failing to achieve pCR, high sTIL was not associated with improved DFS; outcomes were comparable to those with low sTIL without pCR. Thus, high sTIL at baseline does not appear to confer an intrinsic prognostic benefit in the absence of pCR.

scholarly journals Age-Related Biology of Early-Stage Operable Breast Cancer and Its Impact on Clinical Outcome

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1417
Author(s):  
Binafsha M. Syed ◽  
Andrew R. Green ◽  
Emad A. Rakha ◽  
David A.L. Morgan ◽  
Ian O. Ellis ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Early Stage ◽  
Histological Grade ◽  
Survival Rates ◽  
Growth Factor Receptor ◽  
Progesterone Receptors ◽  
Biological Characteristics ◽  
Cancer Specific Survival ◽  
Age Related ◽  
Significant Difference

As age advances, breast cancer (BC) tends to change its biological characteristics. This study aimed to explore the natural progression of such changes. The study included 2383 women with clinically T0-2N0-1M0 BC, managed by primary surgery and optimal adjuvant therapy in a dedicated BC facility. Tissue micro-arrays were constructed from their surgical specimens and indirect immunohistochemistry was used for analysis of a large panel (n = 16) of relevant biomarkers. There were significant changes in the pattern of expression of biomarkers related to luminal (oestrogen receptor (ER), progesterone receptors (PgR), human epidermal growth factor receptor (HER-2), E-cadherin, MUC1, bcl2 CK7/8, CK18 and bcl2) and basal (CK5/6, CK14, p53 and Ki67) phenotypes, lymph node stage, histological grade and pathological size when decade-wise comparison was made (p < 0.05). The ages of 40 years and 70 years appeared to be the milestones marking a change of the pattern. There were significantly higher metastasis free and breast cancer specific survival rates among older women with ER positive tumours while there was no significant difference in the ER negative group according to age. Biological characteristics of BC show a pattern of change with advancing age, where 40 years and 70 years appear as important milestones. The pattern suggests <40 years as the phase with aggressive phenotypes, >70 years as the less aggressive phase and 40–70 years being the transitional phase.

scholarly journals Organ motion in linac-based SBRT for glottic cancer

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Annarita Perillo ◽  
Valeria Landoni ◽  
Alessia Farneti ◽  
Giuseppe Sanguineti
Keyword(s):  
Early Stage ◽  
Displacement Vector ◽  
Thyroid Cartilage ◽  
Three Dimensional ◽  
Target Volume ◽  
Glottic Cancer ◽  
Organ Motion ◽  
Delivery Times ◽  
Significant Difference ◽  
Pre Treatment

Abstract Purpose The purpose of this study is to evaluate inter- and intra-fraction organ motion as well as to quantify clinical target volume (CTV) to planning target volume (PTV) margins to be adopted in the stereotactic treatment of early stage glottic cancer. Methods and materials Stereotactic body radiotherapy (SBRT) to 36 Gy in 3 fractions was administered to 23 patients with early glottic cancer T1N0M0. Patients were irradiated with a volumetric intensity modulated arc technique delivered with 6 MV FFF energy. Each patient underwent a pre-treatment cone beam computed tomography (CBCT) to correct the setup based on the thyroid cartilage position. Imaging was repeated if displacement exceeded 2 mm in any direction. CBCT imaging was also performed after each treatment arc as well as at the end of the delivery. Swallowing was allowed only during the beam-off time between arcs. CBCT images were reviewed to evaluate inter- and intra-fraction organ motion. The relationships between selected treatment characteristics, both beam-on and delivery times as well as organ motion were investigated. Results For the population systematic (Ʃ) and random (σ) inter-fraction errors were 0.9, 1.3 and 0.6 mm and 1.1, 1.3 and 0.7 mm in the left-right (X), cranio-caudal (Y) and antero-posterior (Z) directions, respectively. From the analysis of CBCT images acquired after treatment, systematic (Ʃ) and random (σ) intra-fraction errors resulted 0.7, 1.6 and 0.7 mm and 1.0, 1.5 and 0.6 mm in the X, Y and Z directions, respectively. Margins calculated from the intra-fraction errors were 2.4, 5.1 and 2.2 mm in the X, Y and Z directions respectively. A statistically significant difference was found for the displacement in the Z direction between patients irradiated with > 2 arcs versus ≤ 2 arcs, (MW test, p = 0.038). When analyzing mean data from CBCT images for the whole treatment, a significant correlation was found between the time of delivery and the three dimensional displacement vector (r = 0.489, p = 0.055), the displacement in the Y direction (r = 0.553, p = 0.026) and the subsequent margins to be adopted (r = 0.626, p = 0.009). Finally, displacements and the subsequent margins to be adopted in Y direction were significantly greater for treatments with more than 2 arcs (MW test p = 0.037 and p = 0.019, respectively). Conclusions In the setting of controlled swallowing during treatment delivery, intra-fraction motion still needs to be taken into account when planning with estimated CTV to PTV margins of 3, 5 and 3 mm in the X, Y and Z directions, respectively. Selected treatments may require additional margins.

scholarly journals Survival rates and prognostic factors in right- and left-sided colon cancer stage I–IV: an unselected retrospective single-center trial

2021 ◽  
Author(s):  
Claudius E. Degro ◽  
Richard Strozynski ◽  
Florian N. Loch ◽  
Christian Schineis ◽  
Fiona Speichinger ◽  
...  
Keyword(s):  
Colon Cancer ◽  
Overall Survival ◽  
Blood Level ◽  
Proportional Hazards ◽  
Survival Rates ◽  
Cox Proportional Hazards ◽  
Stage I ◽  
Cancer Stage ◽  
Single Center ◽  
Significant Difference

Abstract Purpose Colorectal cancer revealed over the last decades a remarkable shift with an increasing proportion of a right- compared to a left-sided tumor location. In the current study, we aimed to disclose clinicopathological differences between right- and left-sided colon cancer (rCC and lCC) with respect to mortality and outcome predictors. Methods In total, 417 patients with colon cancer stage I–IV were analyzed in the present retrospective single-center study. Survival rates were assessed using the Kaplan–Meier method and uni/multivariate analyses were performed with a Cox proportional hazards regression model. Results Our study showed no significant difference of the overall survival between rCC and lCC stage I–IV (p = 0.354). Multivariate analysis revealed in the rCC cohort the worst outcome for ASA (American Society of Anesthesiologists) score IV patients (hazard ratio [HR]: 16.0; CI 95%: 2.1–123.5), CEA (carcinoembryonic antigen) blood level > 100 µg/l (HR: 3.3; CI 95%: 1.2–9.0), increased lymph node ratio of 0.6–1.0 (HR: 5.3; CI 95%: 1.7–16.1), and grade 4 tumors (G4) (HR: 120.6; CI 95%: 6.7–2179.6) whereas in the lCC population, ASA score IV (HR: 8.9; CI 95%: 0.9–91.9), CEA blood level 20.1–100 µg/l (HR: 5.4; CI 95%: 2.4–12.4), conversion to laparotomy (HR: 14.1; CI 95%: 4.0–49.0), and severe surgical complications (Clavien-Dindo III–IV) (HR: 2.9; CI 95%: 1.5–5.5) were identified as predictors of a diminished overall survival. Conclusion Laterality disclosed no significant effect on the overall prognosis of colon cancer patients. However, group differences and distinct survival predictors could be identified in rCC and lCC patients.

Systematic review of adjuvant therapy for early stage (epithelial) ovarian cancer

2003 ◽  
Vol 13 (4) ◽  
pp. 395-404 ◽  
Author(s):  
B. Winter-Roach ◽  
L. Hooper ◽  
H. Kitchener
Keyword(s):  
Systematic Review ◽  
Ovarian Cancer ◽  
Adjuvant Chemotherapy ◽  
Adjuvant Therapy ◽  
Early Stage ◽  
Meta Analysis ◽  
Disease Free Survival ◽  
Significant Difference ◽  
Well Differentiated ◽  
Platinum Chemotherapy

A systematic review and meta analysis has been undertaken in order to evaluate the effectiveness of adjuvant therapy following surgery for early ovarian cancer. Trials reported since 1990 have been of a higher quality enabling a meta analysis of adjuvant chemotherapy vs adjuvant radiotherapy and a meta analysis of adjuvant chemotherapy vs observation. There was no significant difference between radiotherapy and chemotherapy, though these comprised studies which demonstrated considerable heterogeneity. Chemotherapy did confer significant benefit over observation in terms of both overall and disease free survival. Except for women in whom adequate surgical staging has revealed well differentiated disease confined to one or both ovaries with intact capsule, platinum chemotherapy should be offered to reduce risk of recurrence.

Differential response rates in early-phase cancer clinical trials (EPCCT).

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3133-3133
Author(s):  
Rozana Abdul Rahman ◽  
Neethu Billy Graham Mariam ◽  
Hitesh Mistry ◽  
Sreeja Aruketty ◽  
Matt Church ◽  
...  
Keyword(s):  
Proportional Hazards ◽  
Performance Status ◽  
Objective Response ◽  
Progression Free Survival ◽  
Response Rates ◽  
Primary Objective ◽  
Cox Proportional Hazards ◽  
Sustained Response ◽  
Phase Ii Trials ◽  
Significant Difference

3133 Background: The primary objective of EPCCT (phase I and non-randomised phase II trials) is to determine the safety and tolerability of new therapeutic agents. Response rates (RR) in these trials have typically been reported at around 10-15%. Increasingly RR and survival outcomes are now investigated in EPCCT as primary or secondary objectives. Methods: Retrospective data analysis was performed on patients (pts) enrolled onto an EPCCT between January 2018 and December 2019 at The Christie NHS Foundation Trust, UK. Data on demographics, prior systemic treatment, sites of disease, performance status, comorbidities, types of therapy, RR, progression free survival (PFS), and overall survival (OS) were collected. Statistical analyses were performed with univariable and multivariable models. Objective response rate (ORR) was defined as the proportion of pts with complete response (CR) and partial response (PR). Duration of response (DOR) was from initial response to progressive disease (PD). Disease control rate (DCR) was defined as CR+PR+ stable disease (SD). Results: A total of 247 pts were treated across 46 EPCCTs. Median age 61 years; 57% female. Sixty-six percent of pts had ≥2 lines of treatment and the majority were ECOG PS 0/1 (98%). Eighty-one percent of pts had ≥2 sites of metastatic disease, and 13 major tumour types were included. Monotherapy trials (159 pts) were predominantly targeted therapies (TT; 60%), or immunotherapies (IO; 20%). Combination therapy trials (88 pts) were TT-based (68%) or IO-based (32%). Data for RR analyses was available for 231 pts. ORR across all trials was 15% (CR 2%) and DCR was 63%. The median DOR was 8.3 months (mos) (95% CI: 7.0 – 9.7) with 28% of pts responding for >6 mos and 7% for >12 mos. ORR in pooled IO treated pts was 27%, DCR was 65% with sustained response >6 mos seen in 37% of these pts. ORR in pooled TT treated pts was 9.4%, DCR was 60% and sustained response > 6 mos seen in 25% of pts. ORR for IO v TT treated pts was significantly different, p=0.007 (pearson chi square), but no significant difference was seen for DCR. Median PFS for all patients was 5.0 mos (95% CI: 4.1 – 6.0) and OS was 10.4 mos (95% CI: 8.4 – 13.0). OS for those with a PR is not reached (HR for PR v PD, 0.006 (95% CI: 0.002 – 0.18). Pts with SD appear to have significantly better OS compared to those with PD (14.6 v 4.2 mos, HR 0.2 (95% CI: 0.1 – 0.3). Multivariable Cox proportional hazards analysis for OS was significant for male gender (HR 1.9, p=0.002), presence of liver metastasis (HR 2.0, p=0.001), low Hb (HR 0.8, p=0.03) and log (LDH) (HR 1.9, p<0.001). Conclusions: Two-thirds of pts enrolled on EPCCTs benefitted in terms of DCR with significant OS improvement in those with PR and SD. Higher ORR were seen in pts receiving IO-based treatments however DCR was similar in IO and TT pts. Gender, presence of liver metastases, Hb count and LDH level contributed significantly to survival differences.

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