Evaluation of Unusual and Highly Aggressive Variant of Endometrium Cancer: Nonendometrioid Endometrium Carcinoma of the Uterus

2015 ◽  
Vol 103 (6) ◽  
pp. 551-556 ◽  
Author(s):  
Fatma Sert ◽  
Ugur Yılmaz ◽  
Senem Alanyalı ◽  
Arif Aras ◽  
Zeynep Ozsaran
Keyword(s):  
Prognostic Factors ◽  
Postoperative Radiotherapy ◽  
Disease Free Survival ◽  
Myometrial Invasion ◽  
Stage Iv ◽  
Stage I ◽  
Factors Affecting ◽  
Endometrium Carcinoma ◽  
Grade 3

Aims To evaluate the survival and treatment outcomes of patients with nonendometrioid endometrium carcinoma after postoperative radiotherapy. Methods The records of 94 patients treated with postoperative radiotherapy (RT) between January 2005 and December 2011 were retrospectively reviewed. Postoperative RT was delivered with a dose of 45-50.4 Gy with 1.8 Gy daily fractions and brachytherapy was added to external RT for 62 patients with a dose of 3 × 6 Gy. Median follow-up time was 35 months (range 6-95 months). Results Median age was 63 years (range 43-83 years) and lymph node metastasis (LNM) was positive in 15 (16.0%) patients. The stage distribution of the patients was as follows: stage I, 58 (61.7%); stage II, 16 (17.0%); stage III, 18 (19.1%); stage IV, 2 (2.2%). Five-year locoregional control (LRC), disease-free survival (DFS), and overall survival (OS) rates were 92.3%, 68.2%, and 78.6%, respectively. In univariable analysis, it was determined that the factors affecting OS rates were stage (p = 0.003), presence of LNM (p = 0.003), and presence of lymphovascular space invasion (LVSI) (p = 0.007); factors affecting DFS rates were stage (p = 0.019), presence of LVSI (p = 0.002), and having LNM (p = 0.049); and the factor affecting LRC rates was tumor size (>5 cm) (p = 0.011). In subgroup analyses, among all stage I patients, the DFS rates were lower for those with histologic grade 3 tumors and more than ½ myometrial invasion. Conclusions Due to its rarity, the prognostic factors and outcomes of nonendometioid endometrium carcinoma are not fully understood. In our analysis, stage, LNM, and presence of LVSI were found to be the most important prognostic factors. In order to tailor the optimal treatment strategy, prospective studies are needed.

Postoperative LV5FU2 combination chemotherapy in patients with curative resected advanced gastric cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15660-e15660
Author(s):  
H. Lee ◽  
K. Lee ◽  
E. Park ◽  
I. Hwang ◽  
J. Jang ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Continuous Infusion ◽  
Advanced Gastric Cancer ◽  
Cancer Progression ◽  
Disease Free Survival ◽  
Stage Iv ◽  
Postoperative Chemotherapy ◽  
Free Survival ◽  
Grade 3

e15660 Background: To illuminate the effect and toxicity of fortnightly low-dose leucovorin(LV) and fluorouracil(5FU) bolus plus continuous infusion(LV5FU2) postoperative chemotherapy(adjuvant) in patients with curative resected, advanced gastric cancer. Methods: Total 40 patients were enrolled in this study. All patients received LV 20mg/m2(bolus), 5FU 400mg/m2(bolus), 5FU 600mg/m2(24-hour continuous infusion) on day 1, 2, 15, and 16, every 4 weeks(LV5FU2), total 6 cycles. Results: Postoperative chemotherapy was initiated median 19 days after surgery. Total of 238 cycles were administered and median follow-up was 602 days. The median disease-free survival time was 728 days (95% CI, 411∼1045) and 2-year overall survival was 77%. Relapses were reported in 18 (45%) of the patients : Two of 9 patients relapsed in stage IIIA (22.2%), seven of 12 patients relapsed in stage IIIB (58.3%) and nine of 17 patients relapsed in stage IV (52.9%). They were all distant relapsed. Eight patients died. 7 patients died as a result of cancer progression and 1 patient suicided while receiving palliative chemotheraphy for cancer relapse. The grade 3∼4 toxicity of neutropenia 8.4% and anemia 0.4%, neutropenic fever 0.4% were observed. Conclusions: Postoperative LV5FU2 adjuvant chemotherapy is effective and tolerable for the patients with curative resected, advanced gastric cancer. No significant financial relationships to disclose.

Primary bone lymphoma (PBL) real world experience of a single cancer hospital. results, prognostic factors, treatment and long term follow up of 12 patients.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e19033-e19033 ◽  
Author(s):  
Dionisios Stoumbos ◽  
Christos Gkekas ◽  
Evangelos Asmanis ◽  
Evangelia Eleni Christaki ◽  
Magdalini Dadakaridou ◽  
...  
Keyword(s):  
Stem Cell ◽  
Prognostic Factors ◽  
Stem Cell Transplantation ◽  
Cell Transplantation ◽  
Autologous Stem Cell Transplantation ◽  
Stage Iv ◽  
Stage I ◽  
Early Stage Disease ◽  
Line Chemotherapy

e19033 Background: PBL is a very rare condition which constitutes less than 1% of all lymphomas. Due to the uncommon entity of this disease there is a lack of concordance in the characteristics, optimal management, treatment strategies and the associated outcome. Methods: Herein, we retrospectively review 12 consecutive patients initially diagnosed with PBL and also treated at our institution from 2001 to present. Results: The median age of the patients was 49 years old. Eight patients were female and 4 male. The histological type of all 12 patients presented was DLBCL. Ten patients (83%) were presented with Ann Arbor Stage I or II disease. While 2 patients (17%) had stage IV disease, none of them showed bone marrow involvement at their initial diagnosis. The median follow-up after achieving CR was 80 months. Our analysis demonstrated that age less than 47 years, lack of B symptoms, normal LDH level, Stage I or II and female gender were found to be favorable prognostic factors for achieving CR and OS. All 12 patients underwent chemotherapy with most of them (10; 83%) receiving 6 to 8 cycles of the RCHOP regimen. The majority (11; 92%) of them received chemotherapy followed by radiotherapy. After front line chemotherapy followed by radiotherapy most patients (9; 75%) achieved CR. Among the remaining three patients, the one patient died before completing first line chemotherapy due to an infection during chemotherapy-induced neutropenia, the other patient is undergoing autologous stem-cell transplantation due to refractory PBL and the third one achieved CR after he underwent high-dose chemotherapy and autologous stem-cell transplantation due to refractory PBL. Both patients that had refractory disease were male and initially diagnosed with stage IV PBL. The median OS was 100 months. Conclusions: The data from our study supports that most PBL patients have had early stage disease (IE-IIE) on diagnosis which also was the most important favorable prognostic factor. Overall, patients with primary lymphoma involving the bone with DLBCL have an excellent prognosis and only a limited number of patients underwent autologous stem-cell transplantation in order to achieve CR.

Location of recurrences in high-risk stage Iendometrial cancer patients not given postoperative radiotherapy: A Danish gynecological cancer group study

2019 ◽  
Vol 29 (3) ◽  
pp. 497-504 ◽  
Author(s):  
Gitte Ørtoft ◽  
Claus Høgdall ◽  
Caroline Juhl ◽  
Lone K Petersen ◽  
Estrid S Hansen ◽  
...  
Keyword(s):  
High Risk ◽  
Postoperative Radiotherapy ◽  
Gynecological Cancer ◽  
Abdominal Cavity ◽  
Myometrial Invasion ◽  
Stage I ◽  
Not Given ◽  
Recurrence Rates ◽  
Cancer Group ◽  
Grade 3

ObjectivesTo study recurrence rates in Danish high-risk stage I endometrial cancers not given radiotherapy in accordance with the decision of the Danish Gynecological Cancer Group.MethodsThis prospective national cohort study includes all 4707 endometrial carcinomas diagnosed from 2005 to 2012. Of these, 623 patients had grade 3 endometroid adenocarcinoma with >50% myometrial invasion or serous/clear/undifferentiated carcinoma (with any depth of invasion). In 305 patients with high-risk stage I on final pathology, 14.1% received adjuvant external beam radiotherapy and 9.6% adjuvant chemotherapy. No patients received brachytherapy. 5-year Kaplan-Meier survival estimates and actuarial recurrence rates were calculated, and adjusted Cox regression analysis used for comparison. Recurrence rates were compared with historical Danish population data (DEMCA 98–99).ResultsFor non-irradiated patients, 5-year overall survival, cancer-specific survival, and progression-free survival rates in high-risk stage I patients were 65%, 78%, and 73%, respectively. For non-irradiated patients, isolated local recurrences were uncommon (vaginal 3.1%, pelvic 0.4%). Death was mainly due to a high occurrence of non-local recurrences, with 8.8% experiencing a first recurrence in the abdominal cavity (outside the field where radiation traditionally have been given) and 13.0% a distant metastasis outside the abdominal cavity. Grade 3 tumors with >50% myometrial invasion seem to be characterized by a different pattern of recurrences, with significantly more isolated vaginal recurrences (7.9% vs 2.2%) and fewer total number of abdominal recurrences (7.9% vs 15.3%) as compared with unfavorable tumor types.ConclusionIsolated vaginal and pelvic recurrences were rare (3–5%) in patients with a final pathologic diagnosis of high-risk stage I endometrial cancer even after the Danish Gynecological Cancer Group decided to omit all types of postoperative radiotherapy and introduce lymph node staging.

A prospective, multicentric clinical study of intensity modulated radiotherapy (IMRT) in nasopharyngeal carcinoma (NPC): A 4-year follow-up report.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16054-e16054
Author(s):  
Fang Wu ◽  
Ren-sheng Wang ◽  
Guosheng Feng ◽  
Guisheng Li ◽  
Meilian Liu ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Distant Metastasis ◽  
Treatment Efficacy ◽  
Disease Free Survival ◽  
Regional Recurrence ◽  
Free Survival ◽  
Number Of Patients ◽  
N Stage ◽  
Grade 3

e16054 Background: To evaluate the treatment efficacy, toxicity and prognostic factors of patients with NPC treated with IMRT. Methods: Between January 2006 and August 2008, 300 patients with pathologically diagnosed NPC from 6 medical center received IMRT. The number of patients with stage I, II, III, IVa-b disease (UICC/AJCC 2002 staging system) was 6, 45,141, and 108, respectively. The prescription doses were as follows: 70~74Gy/30 fraction to GTVnx, 68~70Gy/30 fraction to GTVnd, 60~64Gy/30 fraction to CTV1,50~54Gy /30 fraction to CTV2. Patients with stage III, IVa-b disease also received cisplatin-based chemotherapy. Results: The median follow-up time was 47.1 months (range,11-68 months). There were 18,15 and 42 patients who had developed local, regional recurrence and distant metastasis, respectively. There were 45 patients died. 34 patients died of distant metastasis,6 died of local and regional recurrence, 2 died of re-treatment, one died of hemorrhage complications of nasopharynx,one died of second primary tumor, and the other one died of unknown cause.The 4-year rate of local control (LC), regional control(RC), metastasis-free survival(DMFS),disease-free survival(DFS) and overall survival(OS) was 94.0%, 95.5%, 87.4%, 80.8%, 86.1%, respectively. Multivariate analysis showed that N stage was the only prognostic factor for OS (x2=3.912, p=0.048, HR=14.565), DMFS (x2=5.195, p=0.023, HR=8.737)and DFS (x2=7.613,p=0.006, HR=7.628), in these patients. Mucositis was the most severe acute toxicity, with 18.1% grade 1, 48.6% grade 2, 33.3% grade 3 . No patient suffered from grade 4 mucositis. Xerostomia was the most common seen late toxicity, with 8% grade 0, 50.5% grade 1, 4.6% grade 2. No grade 3-4 xerostomia was observed. Conclusions: IMRT can improve the treatment efficacy of patients with NPC. The acute and late toxicities were tolerated. Distant metastasis becomes the main treatment failure. N stage is a significant prognostic factors.

Pathological Stage I Endometrial Carcinoma: The Role for Adjuvant Radiotherapy

1993 ◽  
Vol 79 (6) ◽  
pp. 405-409 ◽  
Author(s):  
Massad Barhum ◽  
Moshe Stein ◽  
Eduardo Ronsenblatt ◽  
Janet Dale ◽  
Abraham Kuten
Keyword(s):  
Radiation Therapy ◽  
High Risk ◽  
Endometrial Carcinoma ◽  
Adjuvant Radiotherapy ◽  
Postoperative Radiotherapy ◽  
Disease Free Survival ◽  
Myometrial Invasion ◽  
Stage I ◽  
Pathological Stage ◽  
Postoperative Radiation Therapy

Background In order to assess the efficacy of adjuvant radiotherapy in the treatment of pathological stage I endometrial carcinoma, we performed a retrospective analysis of 158 patients with this diagnosis who after surgery were either treated with radiation therapy or only followed from January 1980 through December 1987. Methods Patients were divided into two prognostic categories, high and low risk, on the basis of three known predictors of survival: histology, differentiation, and depth of myometrial invasion. All patients underwent total abdominal hysterectomy and bilateral salpingooophorectomy but only the high risk group received radiotherapy as well. Results After a median follow up time of 59 months the survival rates of the two groups were similar. The 5-year disease-free survival of the surgery alone group was 92 % compared to 89 % for the postoperative radiotherapy group. Side effects of treatment were minimal. Conclusions Postoperative radiation therapy for high risk pathological stage I endometrial carcinoma is an effective adjuvant therapy and confers an excellent prognosis.

Breast cancer experience in Uruguay: A 21-year follow up of 1,906 patients in the same institution

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 21163-21163
Author(s):  
G. D. Krygier ◽  
E. Barrios ◽  
S. Cataldi ◽  
A. Vazquez ◽  
R. Alonso ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Prognostic Factors ◽  
Latin American ◽  
Stage Iv ◽  
Stage I ◽  
Stage Ii ◽  
Node Negative ◽  
Incidence And Mortality

21163 Background: Breast cancer is the most common tumor arising in Uruguaian women accounting for 1,930 patients/year (adjusted incidence ratio 83.1/100,000) with 637 death/year (adjusted mortality ratio 24.1/100,000). Both incidence and mortality rank Uruguay at the top of the latinamerican countries ( IARC-GloboCan 2002). We are presenting our final results with 1,906 patients followed during a 21 year period in the biggest private Institution in our country (CENDIMA) and probably amongst all other latin-american countries. Methods: Although this study was initially designed to find a relationship between prognostic factors and survival parameters: OS (overall survival) and DFS (disease free survival) it also describes the epidemiological features of a big breast cancer population in the top ranked country for breast cancer incidence and mortality in Latin America. Statistical analysis was calculated with SPSS (11.0 version) and SAS (6.0 version) programs. OS and DFS results were obtained through Kaplan Meier method. Log rank test was implemented for univariate analysis and Cox proportional hazard rates were used for multivariate analysis. Results: The median age at diagnosis was 61.0 (SD 13.5). Ductal infiltrating carcinoma (DIC) accounted for more than 80% of patients and 56% were node negative (N0) patients at diagnosis. Stratification was: Stage 0: 8.6%, Stage I: 31.5%, Stage II: 41.8%, Stage III: 16.6%, Stage IV: 1.5%. For OS, the axillary status and hystologic grade showed the highest relative ratio (RR) value: 2.49 and 2.40. The nodal status was the main prognostic factor related to DFS with a 2.2 RR. The five and ten year survival rate was: 0.96 and 0.92 (stage I), 0.84 and 0.71 (stage II), 0.71 and 0.56 (stage III) and 0.39 and 0.29 (stage IV) respectively. Conclusions: This is the final analysis of our population in Uruguay representing the biggest report in breast pathology in a latin-american country with a long follow up period (more than 20 years). Our “good” survival results may reflect the initially low risk population at diagnosis (56% node negative, 40.1% stage 0-I ). Nodal status, histologic grade and staging at diagnosis were independent prognostic factors in univariate and multivariate analysis. No significant financial relationships to disclose.

Prognostic factors in women 45 years of age or younger with endometrial cancer

2008 ◽  
Vol 18 (2) ◽  
pp. 324-328 ◽  
Author(s):  
P. Uharček ◽  
M. Mlynček ◽  
J. Ravinger ◽  
M. Matejka
Keyword(s):  
Endometrial Cancer ◽  
Prognostic Factors ◽  
Clear Cell ◽  
Young Patients ◽  
Myometrial Invasion ◽  
Stage Iv ◽  
Clinical History ◽  
Poorly Differentiated ◽  
Well Differentiated

The purpose of this study was to conduct a clinical and pathologic review of endometrial cancers diagnosed in women aged younger than 45 years to better identify the prognostic factors for this subgroup of women. We retrospectively evaluated the clinical history, treatment, and follow-up of patients with histologically confirmed endometrial cancer treated in Faculty Hospital Nitra, Slovakia from 1993 to 2003. Data were abstracted regarding tumor histology, grade, age, parity, stage, diabetes, use of oral contraceptives, body mass index (BMI), and survival. One hundred seventy-three patients with endometrioid histology were divided into two groups: younger group (age ≤45 years, n= 20) and older group (age >45, n= 153). Patients with high-risk histology (clear cell or serous papillary) were excluded from the study. Twenty patients less than or equal to 45 years of age received treatment for endometrial cancer: stage I, 16 (80%); stage II, 2 (10%); stage III, 1 (5%); and stage IV, 1 (5%). Tumors were well differentiated in 12 (60%), moderately differentiated in 6 (30%), and poorly differentiated in 2 (10%). Age ranged from 28 to 45 years (mean 37), with mean BMI 35.8 ± 9.4. At the end of study period, 17 (85%) were alive with no evidence of disease and 3 (15%) had died of recurrent disease. We conclude that patients less than or equal to 45 years of age have better survival compared to older patients. Deeper myometrial invasion was significantly associated with age greater than 45 years. Majority of young patients with endometrial cancer were obese and nulliparous.

CLINICO-PATHOLOGICAL AND RADIOLOGICAL PROGNOSTIC FACTORS IN CANCER CERVIX TREATED WITH CONCURRENT CHEMORADIATION

2016 ◽  
Vol 1 (1) ◽  
Author(s):  
Manraj S. Kang ◽  
Kamal Sahni ◽  
Piyush Kumar ◽  
Rajneesh Madhok ◽  
Ratna Saxena ◽  
...  
Keyword(s):  
Prognostic Factors ◽  
Mitotic Index ◽  
Univariate Analysis ◽  
Disease Free Survival ◽  
Concurrent Chemoradiation ◽  
P Value ◽  
Publication Date ◽  
Cancer Cervix ◽  
Stage Ib

<bold>Introduction:</bold> Cervical cancer is most common cancer in the rural and second most common in urban areas of our country. It accounts for 16% of all cancers. There are various clinical, Paper Submission Datepathological and radiological factors which dictate the prognosis of these cancer cervix patients. The present study evaluates clinical, pathological and radiological prognostic factors in cancer cervix treated with concurrent chemoradiation. <bold>Material and Methods:</bold> A total of 32 patients seen between 2012 and 2014 patients planned concurrent chemoradiation were evaluated in terms of clinical (age, stage, Hb% and HPV Paper Publication Date infection), pathological (histopathology type and subtype, grade, mitotic index, lymph-July 2016 vascular invasion and necrosis) and radiological (parametrial extension, disease dimension, lymph node, hydronephrosis and vascularity of tumour) prognostic factors. After pre-DOI treatment evaluation patient was planned for 3 Dimentional-Conformal Radiotherapy (50Gy/25#/5 weeks) with concurrent chemotherapy (Cisplatin 35mg/m<sup>2</sup>) followed by 3 applications of Intracavitary radiotherapy (6Gy/fraction) with 6 months follow up. Response was accessed according to WHO response criteria and univariate analysis was done using chi-square test. <bold>Results:</bold> Clinical factors: Age – better disease free survival in older patients (p value=0.003), stage - Lower stage had better survival (for stage Ib-IIa vs stage IIb p value = 0.003 and for stage Ib vs. IIIb p value = 0.0005), Hb% - 57% patients with Hb <10g/dl had recurrence at end of 6 months (p value=0.00001), HPV – High recurrence with HPV presence. Pathological factors like high Mitotic Index had more residual disease (p=0.0009), grade - No statistical significance. Radiological factors- volume of disease - 35 % patients with volume of disease > 6 cm had disease at end of 6 months, hydronephrosis - 40 % patient with hydronephrosis had recurrence (p value = 0.0005) at end of 6 months follow up and vascularity of tumour showed statistically no difference. <bold>Conclusion:</bold> Hb <10%, HPV infection, Mitotic index (3-5/HPF), stage IIIB, pelvic nodes were concluded as the independent poor prognostic factors.

Analysis of Conservative Surgical Treatment and Prognosis of Microinvasive Squamous Cell Carcinoma of the Cervix Stage IA1: Results of Follow-Up to 20 Years

2017 ◽  
Vol 27 (2) ◽  
pp. 357-363 ◽  
Author(s):  
Caio Augusto Hartman ◽  
Julio Cesar Teixeira ◽  
Sergio Bruno Barbosa ◽  
Stephanye Mariano Figueiredo ◽  
Liliana Aparecida Lucci De Angelo Andrade ◽  
...  
Keyword(s):  
Residual Disease ◽  
Disease Free Survival ◽  
Cervical Neoplasia ◽  
Good Prognosis ◽  
Positive Cone ◽  
Definitive Treatment ◽  
Younger Women ◽  
Grade 3 ◽  
Almost All

ObjectiveThe aim of this study was to evaluate the prognosis and recurrence of microinvasive squamous cervical (MIC) cancer stage IA1 in women treated conservatively or by hysterectomy, and followed-up to 20 years.MethodsIt was studied in a cohort of 139 women with MIC, 41 definitively managed by conization and 98 by hysterectomy from January 1994 to December 2003 and followed-up until 2013. The definitive treatment, age, conization technique (loop electrosurgical excision procedure or cold knife conization), cone margin, residual disease in hysterectomy specimen, and the association with recurrence (intraepithelial cervical neoplasia grade 3/intraepithelial vaginal neoplasia grade 3 or worse, and microinvasive or worse) were analyzed.ResultsThere were 2.5 times more conservative treatment in younger women than older (>40 years), and high proportion of residual disease in hysterectomy specimens (67% of intraepithelial cervical neoplasia grade 3 or worse), more common if positive cone margin (74% vs 35%, P < 0.002). There were 2.3% (3/133) recurrences detected as microinvasive or worse, and 6% (8/133) recurrences detected as intraepithelial cervical neoplasia grade 3/intraepithelial vaginal neoplasia grade 3 or worse: 7.3% (3/41) in the conization group and 5.4% (5/92) in the hysterectomy group (P = 0.701). Almost all recurrences (88%, 7/8) were diagnosed until 36 months after treatment, and they were not associated with conization technique. There were no differences in risk of recurrence and overall disease-free survival time related to type of treatment.ConclusionsThis study demonstrates the good prognosis of MIC, regardless the treatment. When fertility is not a concern, hysterectomy should be considered as definitive treatment to avoid the risk of residual disease. Regular follow-up for a long period should be maintained.

First-line nivolumab (NIVO) plus ipilimumab (IPI) plus two cycles of chemotherapy (chemo) versus chemo alone (4 cycles) in patients with advanced non-small cell lung cancer (NSCLC): Two-year update from CheckMate 9LA.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 9000-9000
Author(s):  
Martin Reck ◽  
Tudor-Eliade Ciuleanu ◽  
Manuel Cobo ◽  
Michael Schenker ◽  
Bogdan Zurawski ◽  
...  
Keyword(s):  
Clinical Benefit ◽  
Performance Status ◽  
Objective Response ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Expression Level ◽  
First Line ◽  
Ecog Performance Status ◽  
Grade 3

9000 Background: In the randomized phase 3 CheckMate 9LA trial (NCT03215706), first-line NIVO + IPI combined with 2 cycles of chemo significantly improved overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) vs chemo alone (4 cycles). Clinical benefit was observed regardless of programmed death ligand 1 (PD-L1) expression level and histology. Here we report data with 2 years’ minimum follow-up from this study. Methods: Adult patients (pts) with stage IV / recurrent NSCLC, ECOG performance status ≤ 1, and no known sensitizing EGFR/ALK alterations were stratified by PD-L1 (< 1% vs ≥ 1%), sex, and histology (squamous vs non-squamous) and were randomized 1:1 to NIVO 360 mg Q3W + IPI 1 mg/kg Q6W + chemo (2 cycles; n = 361) or chemo alone (4 cycles; n = 358). Pts with non-squamous NSCLC in the chemo-alone arm could receive pemetrexed maintenance. The primary endpoint was OS. Secondary endpoints included PFS and ORR by blinded independent central review, and efficacy by different PD-L1 levels. Safety was exploratory. Results: At a minimum follow-up of 24.4 months for OS (database lock: Feb 18, 2021), pts treated with NIVO + IPI + chemo continued to derive OS benefit vs chemo, with a median OS of 15.8 months vs 11.0 months, respectively (HR, 0.72 [95% CI, 0.61–0.86]); 2-year OS rates were 38% vs 26%. Median PFS with NIVO + IPI + chemo vs chemo was 6.7 months vs 5.3 months (HR, 0.67 [95% CI, 0.56–0.79]); 8% and 37% of pts who had disease progression received subsequent immunotherapy, respectively. ORR was 38% with NIVO + IPI + chemo vs 25% with chemo. Similar clinical benefit with NIVO + IPI + chemo vs chemo was observed in all randomized pts and across the majority of subgroups, including by PD-L1 expression level (Table) or histology. Any grade and grade 3–4 treatment-related adverse events were reported in 92% and 48% of pts in the NIVO + IPI + chemo arm vs 88% and 38% in the chemo arm, respectively. Conclusion: With 2 years’ minimum follow-up, first-line NIVO + IPI + chemo demonstrated durable survival and benefit versus chemo in pts with advanced NSCLC; no new safety signals were identified. Clinical trial information: NCT03215706. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document