scholarly journals Estado da arte da radioterapia estereotáxica para carcinoma do pulmão de não pequenas células – Experiência de uma instituição

Author(s):  
Catarina Travancinha ◽  
◽  
Nelson Ferreira ◽  
Raquel Barroso ◽  
Susana Esteves ◽  
...  

Introdução: A Radioterapia Estereotáxica Fraccionada (SBRT) é a principal alternativa à cirurgia para doentes com carcinoma de pulmão de células não pequenas (CPNPC) em estádio clínico I ou II que apresentem comorbilidades significativas que impeçam a ressecção segura ou para aqueles que recusem a cirurgia. Métodos: Foram analisados os doentes com CPNPC em estádio clínico I ou II tratados com SBRT na nossa instituição, entre Janeiro de 2015 e Dezembro de 2019, retrospectivamente. As características dos doentes, resultados relacionados com o tratamento e toxicidades foram analisados. As taxas de controlo e sobrevivência foram calculadas pelo método de Kaplan -Meier. As toxicidades aguda e tardia foram classificadas de acordo com o CTCAE v4.0. Resultados: Foram identificados 110 doentes, 78 homens e 32 mulheres, com uma idade mediana de 75,5 anos (50 -90 anos) e um status performance ECOG de 0 ou 1 em 73% desses doentes. Biópsia comprovada em 65% dos casos, dos quais 36% eram adenocarcinomas (ADC) e 21% carcinomas pavimento -celulares (CPC). 65% dos doentes foram estadiados como IA (T1N0), 33% como IB (T2aN0) e 2% como IIB (T3N0), todos estadiados clinicamente com PET -CT. A maioria dos tumores (70%) tinha localização periférica, e a mediana de tamanho era de 24.3mm. 48 Gy em 4 frações foi o esquema mais utilizado (70%), seguido de 50 Gy em 5 frações (17,3%). 110 doentes foram elegíveis para avaliação de recidiva. Com um follow‑up mediano de 53 meses (IC95% 42 a 57 meses), 32 doentes (29.1%) tiveram recidiva da doença, dos quais: 10% local, 7.3% regional e 22.7% à distância. O controlo local (CL) aos 2 e 5 anos foi de 91% e 85%, respectivamente. Ainda aos 2 e 5 anos, o controlo regional (CR) foi de 92% em ambos os casos, a sobrevivência livre de metástases (SLM) de 80% e 67% e a sobrevivência global (SG) de 75% e 45%, respectivamente. SG mediana foi de 51,3 meses. Nenhuma toxicidade de grau ≥3 foi relatada. Toxicidade tardia de grau 2 ocorreu em 26% dos doentes (11% pneumonite, 7% fadiga, 2% fractura de costela, 4% dor na parede torácica, 2% esofagite). Os factores de prognóstico correlacionados com melhor SG foram a idade inferior a 70 anos (p=0.03), o sexo feminino (p=0.005), a ausência de comorbilidades cardíacas e/ou pulmonares (p=0.03) e o bom performance status 0 -1 (p=0.001). Conclusão: Na nossa população de doentes com CPNPC em estádio inicial (I/II) tratados com SBRT, foi alcançado um controlo local e resultados de sobrevivência muito favoráveis, com óptimo perfil de toxicidade, resultados comparáveis com séries publicadas na literatura, reforçando assim o papel da SBRT como tratamento seguro e eficaz nestes doentes.

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 7127-7127 ◽  
Author(s):  
J. P. Allerton ◽  
C. T. Hagenstad ◽  
R. T. Webb ◽  
G. B. Smith ◽  
R. Birch ◽  
...  

7127 Background: Abraxane (A) is a cremophor free, albumin-bound nanoparticle of paclitaxel (P) approved for the treatment of metastatic breast cancer. Belani et al. (JCO 21: 2933–2939, 2003) reported that P 100 mg/m2 days 1, 8 and 15 q 28 days with C AUC 6 on day 1 led to a 32% response rate in 132 patients (pts) with NSCLC. The median time to progression (TTP) was 35 weeks (wks) for stage IIIB and 29 wks for stage IV. Methods: This study was designed to determine if substituting A for P at an identical dose would lead to an improved response rate, TTP or decreased toxicity. Results: Fifty-six pts with stage IIIB/IV NSCLC previously untreated with chemotherapy were enrolled. The median age was 66 (range 37 - 83); 37 were male and median ECOG performance status was 1 (range 0–2). Thirteen pts were stage IIIB. Metastases included bone (17), liver (7), brain (2) and lymph nodes (16). Currently a total of 239 cycles of therapy have been administered with a median of 4 (range 1–8) cycles per pt. In 194 (81%) full dose A was administered on days 1, 8 and 15. The table below shows toxicities compared to P: Seven pts (13%) experienced grade (G) 1 neuropathy and 3 pts (5%) experienced G 2 neuropathy. Five pts were inevaluable for response due to removal from study after <2 cycles of treatment (2 died from progressive disease, 2 because of toxicity - thrombocytopenia and neutropenia - and 1 refused). Of 51 evaluable pts 1 (2%) had a complete response and 23 patients (45%) achieved a partial response. Four of 10 evaluable stage IIIB pts obtained a PR. Twenty-one pts were stable for at least 12 weeks of whom twenty remain stable at 12–29 weeks and one progressed at 23 weeks. A total of 13 pts have progressed and 3 pts have died. The Kaplan-Meier estimate of median TTP is 23 wks and maximum follow up is 34 wks. Conclusions: We conclude that combining A and C is tolerable and active in the treatment of newly-diagnosed NSCLC and antitumor activity compares favorably to that of P/C. Further studies are warranted in this population. [Table: see text] [Table: see text]


BMC Urology ◽  
2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Christoph Oehler ◽  
Michel Zimmermann ◽  
Lukas Adam ◽  
Juergen Curschmann ◽  
Marcin Sumila ◽  
...  

Abstract Background In patients presenting with limited nodal recurrence following radical prostatectomy (RP), stereotactic body radiotherapy (SBRT) results might improve with a better case selection. Methods Single-institution retrospective analysis of patients presenting with 1–3 lymph node (LN) recurrences (N1 or M1a) on 18F-Choline PET/CT. Prior therapy included radical prostatectomy (RP) ± salvage radiotherapy (RT), in absence of any systemic therapy. Outcome parameters were biochemical response (BR), time to biochemical recurrence (TBR) and time interval between SBRT and androgen deprivation therapy start (TADT). Time to event endpoints was analysed using Kaplan-Meier method. Potential prognostic factors were examined using univariate proportional hazards regression for TADT and logistic regression for BR. The optimal cut-off point for LN size was calculated using the Contal and O’Quigley method. Results 25 patients fulfilling study criteria were treated with SBRT from January 2010 to January 2015 and retrospectively analysed. Median follow up was 18 months and median LN diameter 10.5 mm. SBRT was delivered to a median dose of 36 Gy in three fractions (range: 30–45 Gy). BR was reached in 52% of cases. Median TBR was 11.9 months and significantly longer in patients with larger LN (Hazard ratio [HR] = 0.87, P = 0.03). Using 14 mm as cut off for LN, median TBR was 10.8 months for patients with small LN (18 patients), and 21.2 months for patients with large LN (6 patients) (P unadjusted = 0.009; P adjusted = 0.099). ADT was started in 32% of patients after a median follow-up of 18 months. Conclusions For PCa patients with 1–3 LN recurrence after RP (± salvage RT), SBRT might result in a better biochemical control when delivered to larger sized (≥ 14 mm) LN metastases. This study is hypothesis generating and results should be tested in a larger prospective trial.


2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 702-702
Author(s):  
Mark Kozloff ◽  
Axel Grothey ◽  
Johanna C. Bendell ◽  
Allen Lee Cohn ◽  
Tanios S. Bekaii-Saab ◽  
...  

702 Background: Median overall survival (OS) in mCRC has significantly improved over the past 20 yrs, but the observed range of OS in pts remains wide; a large percentage of pts have OS <1 yr or >4 yrs. ARIES was a prospective OCS conducted from 2006–2012 that evaluated outcomes in pts receiving BV + chemotherapy (CT) for mCRC in general clinical practice. The objective of this analysis is to examine clinical characteristics of pts with long vs short OS. Methods: This analysis included 1,417/1,550 first-line (1L) BV-treated mCRC pts who died or had complete follow-up on study. Long OS was defined as OS within the upper quartile of the analysis population (range 42–67 mos); short OS was defined as OS within the lower quartile (range 0.3–12 mos). Progression-free survival (PFS) was estimated using Kaplan-Meier methods. Pt and disease characteristics and treatment patterns were described using summary statistics. Results: Pt and disease characteristics are shown in the Table. Median PFS was 22.3 mos (95% CI, 19.9–23.3) vs. 4.9 mos (95% CI, 4.6–5.4), in the long-OS vs. short-OS groups. More pts with long OS received any second-line (2L) therapy (71% vs. 46%), and were exposed to 5-fluorouracil, oxaliplatin, and irinotecan throughout the course of their disease (53% vs. 32%) compared with pts with short OS. KRAS/BRAF mutation status was not collected. Conclusions: Pts with long OS had better baseline performance status, primary tumors more likely to have been resected, and were more likely to have received 2L CT. Additional analyses of detailed treatment patterns and safety are ongoing. Clinical trial information: NCT00388206. [Table: see text]


Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2004-2004
Author(s):  
Athanasios Galanopoulos ◽  
Christos K. Kontos ◽  
Nora-Athina Viniou ◽  
Ioannis Kotsianidis ◽  
Vassiliki Pappa ◽  
...  

Abstract Introduction - Aims: Several prognostic scoring systems have been developed for patients with myelodysplastic syndromes (MDS), including the International Prognostic System (IPSS), the WHO Prognostic Scoring System (WPSS) and the Revised IPSS (IPSS-R). We evaluated the prognostic value of the IPSS-R on an independent group of 2,582 Greek patients with MDS, registered in the Hellenic National MDS Registry. The aim of this multicenter study was to validate the IPSS-R as a predictor for leukemia-free survival (LFS) and overall survival (OS), in newly-diagnosed MDS patients and to compare its prognostic significance with that of IPSS and WPSS. Moreover, to investigate the predictive value of IPSS-R in association with other recognized prognostic variables, such as patient's age, baseline serum lactate dehydrogenase (LDH), and ferritin concentrations, IPSS, WPSS, Eastern Cooperative Oncology Group (ECOG) performance status, transfusion dependency, and response to first-line treatment. Methods: Clinicopathological data from 2,582 MDS patients, diagnosed between 1/2000 - 1/2015 and registered in the Hellenic National MDS Registry were analyzed. Patients with MDS/MPN were excluded. Data included age, gender, date of diagnosis, clinical characteristics, WHO-2008 classification, laboratory parameters, transfusion dependency, bone marrow aspirate and biopsy morphology, cytogenetic findings, and type of treatment. LFS was calculated from the date of initial diagnosis of MDS until bone marrow blast increased to ≥20% [transformation to acute myeloid leukemia (AML), according to the WHO classification], or last contact. OS was defined as the time from MDS diagnosis to death, or last contact. Patients alive and not having developed AML until last follow-up were censored for OS and LFS, respectively. Kaplan-Meier survival analysis and Cox regression analysis were performed with regard to LFS and OS. Differences between Kaplan-Meier curves were evaluated using the Mantel-Cox (log-rank) test. All significant variables identified by univariate Cox regression analysis and clinical factors important for MDS were used to build the multivariate Cox regression models. Multivariate Cox regression analysis included only those patients for whom the status of all variables was known, and comprised age, serum LDH, and ferritin levels, transfusion dependency, response to first-line treatment, IPSS, WPSS, and IPSS-R. Confidence intervals (CI) were estimated at the 95% level; all tests were two-sided, accepting p<0.05 as indicative of a statistically significant difference. All statistical analyses were performed with the statistical software SPSS (version 21). Results: 1,623 male (62.9%) and 959 female MDS patients with a median age of 74 years at diagnosis were included in the current study. Complete follow-up information was available for 2,376 patients. The estimated median OS was 58 months (95% CI = 52.9 - 63.1 months). For 1,974 patients, data used in the calculation of all three scoring systems were complete, thus allowing risk score calculation and comparison of the three risk assessment systems. Median OS was significantly different in patient subgroups classified according to IPSS, WPSS, and IPSS-R, as shown by the Kaplan-Meier survival analysis (p<0.001). Fig. 1 shows Kaplan-Meier OS curves of MDS patients stratified according to IPSS-R (p<0.001). Moreover, the comparison of the prognostic value of the IPSS, WPSS, and IPSS-R revealed that the IPSS-R was significantly superior to both, WPSS and IPSS (p<0.001 in all cases). Multivariate Cox regression analysis demonstrated that the high prognostic value of IPSS-R, in terms of LFS and OS, was independent of patient's age, serum LDH, and ferritin concentration, ECOG performance status, and transfusion dependency (p<0.001). Interestingly, besides IPSS-R, patient age and transfusion dependency retain their small - yet significant - prognostic impact in the multiparametric models, thus implying that these two parameters could add prognostic value to the IPSS-R. Conclusions: Our data support the notion that all three prognostic scores are very useful predictors for both, LFS and OS in MDS, yet IPSS-R is superior to IPSS and WPSS as a prognostic tool, with regard to OS. Disclosures No relevant conflicts of interest to declare.


2014 ◽  
Vol 53 (02) ◽  
pp. 39-45 ◽  
Author(s):  
A. Sabet ◽  
H. Ahmadzadehfar ◽  
J. Bruhman ◽  
A. Sabet ◽  
C. Meyer ◽  
...  

SummaryAim: This retrospective study aims to evaluate the predictive value of FDG PET/CT in patients with unresectable hepatocellular carcinoma (HCC) undergoing radioembolization with yttrium-90 labeled microspheres (RE). Patients, methods: The study cohort comprised 33 patients who were treated with RE at our institution and underwent FDG PET/CT at baseline and four weeks after radioembolization. According to the baseline FDG metabolic status of the HCC lesions, patients were divided into two groups: FDG-negative (n = 12) and FDG-positive (n = 21) HCC. FDG-positive patients were further divided into early metabolic responders and non-re- sponders according to the relative change in SUVmax of the treated lesions. Survival analyses were performed with the Kaplan-Meier method (log-rank test, p < 0.05). Multivariate analysis was performed to assess the influence of prognostic factors on overall survival (OS). Results: FDG-negative patients had a significantly longer OS (13 months, 95%CI 7-19) than FDG-positive patients (9 months, 95%CI 7-11; p = 0.010). Among FDG- positive patients, metabolic responders survived significantly longer than metabolic non- responders (10 months, 95%CI 8-12 vs. 5 months, 95%CI 4-6; p = 0.003). From the other baseline factors (including performance status, hepatic tumour burden, presence of extra-hepatic disease, administered activity) only the BCLC stage had a significant impact on OS (p = 0.028). Conclusion: Pre- and post- therapeutic FDG PET independently predicts overall survival in patients with HCC undergoing radioembolization. Interestingly, early metabolic response seems to be assessable as early as four weeks post-treatment.


Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 3997-3997 ◽  
Author(s):  
Bhausaheb Bagal ◽  
Hasmukh Jain ◽  
Uma Dangi ◽  
Manju Sengar ◽  
Sadhana Kannan ◽  
...  

Abstract Background: Multiple Myeloma is a heterogeneous disease with few patients enjoying overall survival up to a decade while others dying within few years from diagnosis. Multiple staging systems and risk stratification models based on clinical features, laboratory parameters and cytogenetics have been used to predict the response to therapy and outcomes. Positron emission tomography integrated with computerised tomography (PET-CT) offers several advantages as compared to conventional bone imaging modalities in terms of ability to assess extramedulary disease, detection of bone marrow involvement and extent of active disease. Especially important is ability of PET-CT to assess treatment response in terms of FDG activity as bone changes like lytic lesions may persist long on conventional imaging even when disease is in remission. There is scarce data on potential role of PET-CT in response evaluation and prognostication in patients with multiple myeloma. We prospectively analysed the prognostic relevance of PET-CT done prior to autologous stem cell transplant (ASCT). Method: Consecutive patients of multiple myeloma who underwent ASCT between March 2011 and June 2014 were included in this study. All patients received standard novel agent based induction regimen, bortezomib based in 38 patients and lenalidomide based in 5 patients. Patients were evaluated for response by using international myeloma working group (IMWG) criteria after 4-6 cycles of induction regimen. Subsequently patient's stem cells were harvested from peripheral blood by chemomobilization with cyclophosphamide along with G-CSF. All patients underwent PET-CT immediately pretransplant along with response evaluation by IMWG criteria. PET-CT was considered to be negative if there were no FDG avid lytic lesion and no FDG avid extramedulary disease/soft tissue component was seen. Conditioning regimen used for ASCT were melphalan- 200mg/m2 in 37 patients, reduced doses of melphalan (100-140 mg/m2) in 2 patients or bortezomib- melphalan in 4 patients. Post transplant response evaluation was done at 3 months from transplant and at 3 monthly interval thereafter by SIEP, immunofixation, 24 hours urine BJP, and serum free light chain assay. Probabilities of overall survival and progression free survival were estimated using the Kaplan–Meier method and were compared by log rank test. Results: Forty three patients of multiple myeloma underwent ASCT during the study period. The median age of patients at diagnosis was 49 years and 31 (72 %) were male. As per International Staging System, 15 were stage I, 9 were stage II and 14 were stage III disease at time of diagnosis. After induction therapy, 17 patients achieved CR, 13 patients achieved VGPR, 10 patients had PR while 3 patients had progressive disease (PD) pretransplant. Simultaneously done PET-CT was positive in 15 (34%) patients while it was negative in remaining. At a median follow up of 2.6 years from diagnosis 8 patients had progression of disease and 3 patients have died because of disease progression. So as to evaluate the prognostic utility of PET-CT, patients were grouped into four groups as follows- group 1 - CR/VGPR and PET-CT- negative, group 2 - CR/VGPR and PET-CT- positive, group 3 - PR/PD and PET-CT- negative, group 4 - PR/PD and PET-CT- positive as shown in table 1. Table 1: Pretransplant response according to IMWG criteria and PET-CT. PET negative pretransplant PET positive pretransplant Pre transplant CR/VGPR 25 5 Pretransplant PR/PD. 3 10 At a median follow up of 1.68 years post transplant, 4 patients from group 1 and 4 patients from group 4 have progressed. The estimated probability of overall survival and progression free survival from transplant by Kaplan–Meier method at 3 year is 92 % and 62 % respectively. The time to progression after transplant was significantly short in group 4 as compared to group 1 (median time to progression of 6 months versus 26 months; p=0.001). Out of 8 patients who have relapsed post transplant, 3 patients who were PET-CT positive pretransplant have died while all the 4 patients who were PET negative pretransplant are alive. Conclusion: Pretransplant PET-CT positivity predicts early relapse after ASCT. Survival of such patients is poor after relapse post ASCT. These findings needs validation in larger cohort of patients with longer follow up. Disclosures No relevant conflicts of interest to declare.


2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4067-4067 ◽  
Author(s):  
H. K. Sanoff ◽  
D. J. Sargent ◽  
M. E. Campbell ◽  
R. F. Morton ◽  
C. S. Fuchs ◽  
...  

4067 Background: N9741 randomized 1691 patients (pts) to seven 5FU, Ox and Iri containing regimens for MCRC. After 20.4 months median follow-up, FOLFOX and IROX improved time to progression (TTP) and overall survival (OS) compared to IFL. Here we update OS and TTP, and report an analysis of factors prognostic of pt outcome. Methods: 5 yr OS and TTP were calculated by Kaplan-Meier per treatment (rx) arm. Pt factors [rx arm, age, gender, prior adjuvant rx, body mass index (BMI), performance status (PS), number of disease sites (#sites), neutrophil count (ANC), hemoglobin, platelets, bilirubin, alkaline phosphatase (ALK), aspartate aminotransferase (AST)] were assessed for univariate association with OS, TTP, response rate (RR), and any grade =3 toxicity. Associated factors were included in multivariate Cox and logistic regression models. Results: After a median follow-up of 4.3 yrs, FOLFOX treated pts were more likely to live 5 yrs, 9.2% versus 5.4% for IROX (p=.016) and 3.8% for IFL (p<.001). Median TTP was also significantly longer in the FOLFOX arm, 9.2 mo vs 6.5 mo for IROX (p=<.001) and 6.0 mo for IFL (p=<.001). The prognostic model found higher PS, ANC and ALK, and more disease sites were prognostic of worse OS (see table ). Age = 70 was associated with poorer survival (HR death 1.33, p=.03), but not TTP, RR, or grade =3 toxicity. FOLFOX rx was the most powerful prognostic factor for TTP and OS. The odds of grade =3 toxicity were significantly higher in FOLFOX treated pts (OR 1.65, p<.001) and lower in men (OR .63, p<.001). No significant interactions between rx arm and pt factors were present, suggesting no factor examined is predictive of rx-specific outcome. Conclusions: 9% 5 yr OS in MCRC pts treated with first-line FOLFOX sets a new benchmark. We confirmed pre-rx PS, WBC, and ALK are prognostic for OS, though FOLFOX rx was the strongest prognostic factor. No factor was associated with differential outcome or toxicity by rx arm, thus these factors cannot be used to guide rx selection. [Table: see text] [Table: see text]


Hemato ◽  
2021 ◽  
Vol 2 (2) ◽  
pp. 264-280
Author(s):  
Valli De Re ◽  
Laura Caggiari ◽  
Maurizio Mascarin ◽  
Mariangela De Zorzi ◽  
Caterina Elia ◽  
...  

Several studies have examined the prognostic performance of therapeutic groups (TG) and early responses to therapy on positron emission tomography/computed tomography (PET/CT) in children and adolescents with classical Hodgkin lymphoma (cHL); less research has been performed on molecular parameters at diagnosis. The aim of the present study was to devise a scoring system based on the TG criteria for predicting freedom from progression (FFP) in 133 patients: 63.2% males; 14 years median age (interquartile range (IQR) 11.9–15.1); with cHL (108 nodular sclerosis (NS) subtype) treated according to the AIEOP LH-2004 protocol; and median 5.55 (IQR 4.09–7.93) years of follow-up. CHL progressed or relapsed in 37 patients (27.8%), the median FFP was 0.89 years (IQR = 0.59–1.54), and 14 patients (10.5%) died. The FPR (final prognostic rank) model associates the biological HLA-G SNP 3027C/A (numerical point assigned (pt) = 1) and absolute neutrophil count (>8 × 109/L, pt = 2) as variables with the TG (TG3, pt = 3). Results of FPR score analyses for FFP suggested that FPR model (Kaplan–Meier curves, log-rank test for trends) was better than the TG model. At diagnosis, high-risk patients classified at FPR rank 4 and 5 identified 18/22 patients who relapse during the follow-up.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20643-e20643
Author(s):  
Eric S. Nadler ◽  
Janet L. Espirito ◽  
Melissa Pavilack ◽  
Marley Boyd ◽  
Andrea Leninka Vergara-Silva ◽  
...  

e20643 Background: Multiple therapeutic options exist for metastatic non-small cell lung cancer (mNSCLC), including chemotherapy (CH), targeted therapy (T), and immunotherapy (IT). The first IT for mNSCLC was FDA approved in 2015 for use after progression on platinum-based CH and T in patients (pts) with EGFR or ALK mutations. The current study evaluates treatment (tx) patterns and outcomes in mNSCLC pts receiving first- (1L), 2nd- (2L), and 3rd-line (3L) therapy. Methods: This is a retrospective, observational cohort study of mNSCLC pts receiving initial tx from 1/2012–4/2016, with follow-up to 6/2016. Data were obtained from The US Oncology Network/McKesson Specialty Health electronic health records database. Demographics, clinical characteristics, and tx patterns were characterized. Overall survival (OS) was assessed using the Kaplan-Meier method. Results: 10,689 1L pts were identified during the study period. Median age was 68 y, and 54% were male. Most pts (59%) had an ECOG performance status of 1, 77% had nonsquamous histology, and 85% were former or current smokers. Initial tx was CH in 93% of pts. Among pts receiving initial T therapy, most were never smokers (48%) vs initial CH pts (12%; P< 0.0001). Median OS (mOS) for all pts at 1L was 12.3 mo (95% CI, 11.9–12.7), and mOS was significantly longer in pts who received T (24.3 vs 11.7 mo for T vs CH, p< 0.0001). Among pts who received 2L therapy in the study period (n = 4235), 66%, 17%, and 17% received CH, T, and IT respectively. Pemetrexed or docetaxel monotherapy was most commonly used for 2L CH, erlotinib was most used as 2L T, and nivolumab for 2L IT. mOS from start of 2L for CH, T, and IT was 9.2, 11.2, and 9.7 mo, respectively (log rank P= 0.01). In 3L pts (n = 1580), nivolumab was most frequently used (17%), and mOS from 3L for CH, T, and IT was 8.0, 7.4, and 11.3 mo, respectively ( P= 0.0187). Conclusions: These data demonstrate integration of novel therapies for mNSCLC in the community. Longer survival was observed in 2L and 3L patients treated with T and IT as compared with CH. This warrants additional randomized studies to investigate optimal sequencing of these agents.


2019 ◽  
Vol 37 (4_suppl) ◽  
pp. 371-371 ◽  
Author(s):  
Angel Alsina ◽  
Masatoshi Kudo ◽  
Arndt Vogel ◽  
Ann-Lii Cheng ◽  
Won Young Tak ◽  
...  

371 Background: Lenvatinib (LEN) was shown to be noninferior to sorafenib (SOR) for overall survival (OS) in REFLECT (median OS [mOS], 13.6 vs 12.3 months [mo]; HR 0.92; 95% CI 0.79–1.06). LEN was superior vs SOR for secondary endpoints including objective response rate (ORR) per mRECIST: 24.1% vs 9.2% by investigator and 40.6% vs 12.4% by independent review (Kudo M et al. Lancet 2018). We report a posthoc responder analysis of patients (pts) who received first-line LEN in REFLECT and subsequent anticancer medication during survival follow up. Methods: In REFLECT, pts with unresectable hepatocellular carcinoma were randomized 1:1 to receive first-line LEN or SOR. Objective response was defined as complete or partial response by mRECIST per investigator. Pts with disease progression and who discontinued treatment were followed for survival every 12 weeks; subsequent anticancer medication during survival follow up were recorded until time of death. Data cutoff: Nov 13, 2016. mOS was calculated using Kaplan-Meier estimates with 2-sided 95% CIs. Results: In REFLECT, one third of the overall study population (156/478 pts randomized to LEN and 184/476 to SOR) received subsequent anticancer medication, most commonly SOR (25% in LEN arm). ECOG performance status and laboratory assessments, including liver function tests, were comparable between arms prior to subsequent treatments. Among these pts, mOS was 21 vs 17 mo and ORR was 27.6% vs 8.7% for LEN vs SOR arms, respectively. In a subset analysis of LEN responders who received any subsequent anticancer medication (n = 43), mOS was 26 mo (95% CI 18.5–34.6). For SOR responders who received any subsequent anticancer medication (n = 16), mOS was 22 mo (95% CI, 14.6–NE). For LEN responders who subsequently received SOR (n = 35), mOS was 26 mo (95% CI 18.2–34.6). Conclusions: In REFLECT, one third of pts randomized to first-line LEN received subsequent anticancer medication, including SOR, with a mOS of 21 mo. In this exploratory, posthoc analysis of pts who responded to LEN and received any subsequent anticancer medication or SOR, mOS was 26 mo. Clinical trial information: NCT01761266.


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