Should all patients (pts) with advanced biliary cancers receive first-line treatment with cisplatin and gemcitabine (GC)?

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 244-244
Author(s):  
Vanessa Costa Miranda ◽  
Luiza Dib-Faria ◽  
Maria Ignez Freitas Melro Braghiroli ◽  
Jorge Sabbaga ◽  
Daniel Fernandes Saragiotto ◽  
...  
Keyword(s):  
Median Survival ◽  
Cox Regression ◽  
Performance Status ◽  
Multivariable Analysis ◽  
Poor Performance ◽  
Median Number ◽  
Poor Performance Status ◽  
Poor Survival ◽  
First Line ◽  
Dismal Prognosis

244 Background: GC is considered the standard of care for pts with advanced biliary tract cancer (BTC), providing median survival of nearly one year. (Valle J et al. NEJM 2010) Nevertheless, many pts experience poor outcomes, leading to a growing interest to identify pts who might benefit from such treatment. Here we aimed to investigate clinical and laboratory factors associated with poor survival among BTC pts treated with GC. Methods: We retrospectively evaluated all consecutive pts with advanced/metastatic BTC who received first line GC at the Instituto do Cancer do Estado de Sao Paulo, Brazil, in a 2 year-period. Clinical and laboratory variables that could influence pts’ outcomes were gathered from medical charts. Cox regression proportional hazard model was used to investigate the following prognostic factors for death: pre-treatment biliary deobstruction, baseline Ca 19.9, any GC interruptions or dose reductions, baseline ECOG status, Charlson Comorbidity Index (CCI) and age. P values < 0.05 in multivariable analysis were considered significant. Results: From January/2009 to July/2011, 72 pts were identified. The median age was 60 years (range 30-80 years), 45 pts (62.5%) were female and 50 (69.4%) presented baseline ECOG 0-1. The median number of cycles of CG was 4 (range 1-9). Grade 3 /4 neutropenia and thrombocytopenia occurred in 16.6% and 12.5% of pts, respectively. Median survival of the whole cohort was 9.53 months (95% CI: 6.2 - 11.4). Median survival in pts with ECOG 0/1 was 13.5 months (95% CI: 9,5 – NR) and among pts with ECOG 2/3 3,5 months (95% CI: 1-7). In the Cox multivariable model, ECOG 2 /3 versus 0/1 (HR: 8.4, 95% CI: 3.4 to 20.7; p<0.001) and CCI score ≥ 2 (HR: 9.5 95% CI: 1.6 to 55.3; p= 0.012) significantly predicted for poor survival. There was a trend for improved survival among pts who had biliary drainage before starting GC (HR: 2.3 95% CI: 1.0 - 5.3; p= 0.051). Conclusions: In this retrospective cohort of unselected pts with advanced BTC treated with first line GC, poor performance status and multiple comorbid illnesses were associated with dismal prognosis. Treatment with GC should be carefully discussed before being offered to these pts.

scholarly journals Evaluation of the prognostic benefit of identifying the probable primary site in cancer of unknown primary

2015 ◽  
Vol 6 (3) ◽  
pp. 22-28
Author(s):  
Joyutpal Das ◽  
Shahid Gilani
Keyword(s):  
Median Survival ◽  
Cox Regression ◽  
Performance Status ◽  
Disease Onset ◽  
Significant Proportion ◽  
Poor Performance ◽  
Primary Site ◽  
University Hospital ◽  
Unknown Primary ◽  
Poor Performance Status

Abstract With the development of site-specific cancer therapy, identifying the primary origin allows the oncologist to personalise therapy for patients with the cancer of unknown primaries (CUPs). At present, immunohistochemistry (IHC) screening is the standard method used to postulate the primary site in CUP. In this retrospective study, we evaluated the prognostic benefit of identifying the primary site in CUP. All 84 patients who presented with suspected CUP to the Royal Stoke University Hospital between 2011 and 2012 were included in our study. Forty-eight percent (40/84) of these patients were unable to undergo necessary investigations to identify primary sites because of poor performance status. IHC screening was able to postulate the primary site in 59% (26/44) of the remaining patients with confirmed CUP. Therefore, the primary site was not identified in a significant proportion of patients with CUP. The median survival of confirmed CUP with probable primary site was 2.0 months (95% confidence interval (CI): 1.2 to 2.9 months), whereas the median survival of confirmed CUP with no probable primary site was 4.1 months (95% CI: 1.5 to 9.7 months). This difference in survival time was statistically significant. In addition, using the Cox regression model, we found that patients with confirmed CUP with primary sites had prognostically unfavourable diseases with a shorter median survival, regardless of the age of disease onset, gender, sites of metastases or number of metastases. One approach to improve the survival would be to start systemic therapy at the earliest possible opportunity rather than waiting for all investigation results, such as IHC.

Was bei Tumorpatienten mit Atemwegsstenosen die Prognose bestimmt: Erst Rekanalisierung, im Anschluss andere Therapieoptionen nicht versäumen

2020 ◽  
Vol 8 (3) ◽  
pp. 148-149
Author(s):  
Manfred Wagner
Keyword(s):  
Prognostic Factors ◽  
Performance Status ◽  
Survival Rates ◽  
Poor Performance ◽  
University Hospital ◽  
Poor Performance Status ◽  
Poor Survival ◽  
Interventional Bronchoscopy ◽  
Cox Proportional Hazard Regression ◽  
One Year

Background: Malignant central airway obstruction (MCAO) occurs in 20–30% of patients with primary pulmonary malignancy. Although bronchoscopic intervention is widely performed to treat MCAO, little data exist on the prognosis of interventional bronchoscopy. Therefore, we evaluated the clinical outcomes and prognostic factors of bronchoscopic interventions in patients with MCAO due to primary pulmonary malignancy. Methods: This retrospective study was conducted at a university hospital and included 224 patients who received interventional bronchoscopy from 2004 to 2017, excluding patients with salivary gland-type tumor. A multivariable Cox proportional hazard regression analysis was used to identify independent prognostic factors associated with survival after the first bronchoscopic intervention. Results: Among 224 patients, 191 (85.3%) were males, and the median age was 63 years. The most common histological type of malignancy was squamous cell carcinoma (71.0%). Technical success was achieved in 93.7% of patients. Acute complications and procedure-related death occurred in 15.6 and 1.3% of patients, respectively. The median survival time was 7.0 months, and survival rates at one year and two years were 39.7 and 28.3%, respectively. Poor survival was associated with underlying chronic pulmonary disease, poor performance status, extended lesion, extrinsic or mixed lesion, and MCAO due to disease progression and not receiving adjuvant treatment after bronchoscopic intervention. Conclusions: Interventional bronchoscopy could be a safe and effective procedure for patients who have MCAO due to primary pulmonary malignancy. In addition, we found several prognostic factors for poor survival after intervention, which will help clinicians determine the best candidates for bronchoscopic intervention.

Nab-paclitaxel (Nab-P) and gemcitabine (G) as first-line chemotherapy (CT) in advanced pancreatic cancer (APDAC) elderly patients (pts): A “real-life” study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 424-424 ◽  
Author(s):  
Guido Giordano ◽  
Vanja Vaccaro ◽  
Eleonora Lucchini ◽  
Gianna Musettini ◽  
Paola Bertocchi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cox Regression ◽  
Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Real Life ◽  
Median Number ◽  
World Population ◽  
Toxicity Profile ◽  
First Line ◽  
Clinical Records

424 Background: Nab-P and G represents a standard of care in first line APDAC treatment. Neverthless, activity, efficacy and safety of Nab-P + G have not been established in elderly pts and clinical trials on APDAC treatment contain fewer elderly pts compared with everyday clinical practice. Aim of this analysis is to evaluate outcomes and toxicities of elderly pts treated with first line Nab-P + G in a “real world” population. Methods: Clinical records of APDAC pts receiving Nab-P 125 mg/m2 and G 1000 mg/m2on days 1,8 and 15 of a 28 day cycle as first line CT were retrospectively reviewed, investigating activity (Disease Control Rate, DCR: Stable Disease + Partial Response + Complete Response, SD+PR+CR), efficacy (Progression Free Survival, PFS and Overall Survival, OS) and safety. Analysis was then performed in ≥ 70 years group of pts. OS and PFS were estimated with Kaplan-Meyer method with 95% CI. Cox-regression model was applied to the data with univariate and multivariate approach. Results: 105 pts (M/F:58/47), median age 64 (range 37-77) ECOG Performance Status of 0/1/2: 46/41/17 respectively were included in our analysis. 37 pts (35%) were ≥ 70 years old. In overall population Nab-P+G was administered for a median number of 6 cycles (range 1-12). 4 CR, 24 PR and 28 SD were observed (DCR: 53%), median PFS was 7 months (95% C.I. 5.93 - 8.08) and median OS was 11 months (95% C.I. 9.58 – 12.41). Pts aged ≥ 70 received a median number of 5 cycles (range 1 - 10). DCR was 48% (9 PR + 9 SD) with no differences in PFS (6.5 months, 95%C.I. 5.36 – 7.64, p=0.49) and OS (10 months, 95% C.I. 8.53 – 11.47 p=0.67) with < 70 years old pts. Treatment was mildly tolerated and toxicity profile appeared to be different in elderly pts than younger ones with more G3-4 non-haematological (27% vs 15% p=0.03) and fewer haematological (12% vs 29% p=0.004) events respectively. Conclusions: These data, evaluated under daily practice conditions, in absence of clinical trials on APDAC elderly pts, show that pts aged ≥ 70 may benefit of first-line Nab-P and G combination, as well as younger ones, both in terms of response and survival experiencing a tolerable, but significantly different toxicity profile.

Systemic therapy use and outcomes after relapse from accelerated hemithoracic radiation and surgery for malignant pleural mesothelioma (MPM).

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 8559-8559
Author(s):  
Sara V. Soldera ◽  
John Kavanagh ◽  
Melania Pintilie ◽  
Ronald Feld ◽  
Natasha B. Leighl ◽  
...  
Keyword(s):  
Systemic Therapy ◽  
Performance Status ◽  
Poor Performance ◽  
Final Diagnosis ◽  
Rank Test ◽  
Poor Performance Status ◽  
Extrapleural Pneumonectomy ◽  
First Line ◽  
Poor Prognostic Factor ◽  
Surgical Specimen

8559 Background: The prognosis of patients (pts) with MPM remains poor. Accelerated hemithoracic radiation followed by extrapleural pneumonectomy and adjuvant chemotherapy in ypN2 disease (SMART) provides encouraging results. The ability to administer systemic therapy (Tx) and response rate (RR) after recurrence remains unclear. We therefore examined subsequent lines of Tx and outcomes following relapse after SMART. Methods: A retrospective analysis of pts diagnosed with recurrent MPM following SMART was conducted at a single institution. OS was determined from date of relapse to death and was estimated using the Kaplan-Meier method. Potential prognostic variables were tested utilizing the log-rank test. Results: Out of 86 pts undergoing SMART from 2008 to 2016, 53 (62%) developed recurrent disease of which 36% had pathological confirmation. Two cases with initial epithelial subtype on surgical specimen relapsed with different histology (sarcomatoid and small cell). In 48% of pts, relapse was unclear at first imaging (n = 42) and a median of 98 days (range 6-966) lapsed between first suspicion and final diagnosis. The median age at relapse was 66 years (range 45-79), 47% had a performance status (PS) ≥2 (n = 45) and 64% were of epithelial subtype. After a median follow up of 7.6 mo, the median OS was 5.2 mo. PS ≥2 was associated with worse OS (2.8 vs 10.7 mo, p < 0.001). Of 42 pts followed after relapse, 36% received any Tx (19% 1 line; 12% 2 lines; 5% ≥3 lines). Tx was omitted in 62% of pts due to poor PS (26/42). First line Tx consisted of platinum doublet in 93% of pts (n = 15). Of 13 pts with response evaluable disease, RR was 15% (0 CR, 15% PR). Of note, 0/13 pts had neoadjuvant Tx and 3/13 pts had adjuvant Tx (10, 13 and 38 mo lapsed between end of adjuvant Tx and start of Tx in the relapsed setting). 6/15 pts discontinued Tx due to toxicity, 5/15 due to progression and median number of cycles was 4. Conclusions: Pts with relapsed MPM following SMART have poor prognosis and low RR to first line Tx. Poor performance status at relapse is a poor prognostic factor. Earlier detection, novel diagnostic markers of relapse and consideration of maintenance strategies should be investigated in future studies.

Outcomes of patients (pts) with metastatic urothelial cancer (mUC) and poor performance status (PS) receiving anti-PD(L)1 agents.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4525-4525
Author(s):  
Ali Raza Khaki ◽  
Leonidas Nikolaos Diamantopoulos ◽  
Ang Li ◽  
Michael Edward Devitt ◽  
Alexandra Drakaki ◽  
...  
Keyword(s):  
Checkpoint Inhibitors ◽  
Performance Status ◽  
Wholesale Price ◽  
Poor Performance ◽  
Wald Test ◽  
Median Number ◽  
Hospital Death ◽  
Poor Performance Status ◽  
Metastatic Urothelial Cancer ◽  
Ecog Ps

4525 Background: Anti-PD(L)1 immune checkpoint inhibitors (ICI) prolong overall survival (OS) after platinum chemotherapy in mUC. However, clinical outcomes in pts with poor PS at time of ICI initiation are unknown. We hypothesized that ICI initiation in pts with ECOG PS 2-3 would be associated with worse outcomes vs. pts with ECOG PS < 2, and impact death location. Methods: A retrospective cohort study in 8 institutions identified pts with mUC who received ICI. Demographic, clinicopathologic, treatment (tx) patterns, tx response, and outcomes were collected. Primary endpoint: overall response rate (ORR). Secondary endpoints: median (m) OS in pts receiving ICI as 1st and 2nd line (1L, 2L); odds of dying in hospital (vs elsewhere) for pts receiving ICI (vs no tx) within 30 days of death; and estimated drug cost for pts with ICI within 30 days of death based on average wholesale price. Unadjusted logistic regression was used to assess association between ORR and ECOG PS (2-3 vs < 2) and wald test was used to compare mOS between ECOG PS (2-3 vs < 2). Results: 194 consecutive pts (30% women, 41% never smokers, median age at diagnosis 69) treated with ICI for mUC were identified. Median number of total tx lines was 2; all pts received ≥1 ICI line (6 pts received 2 ICI lines); 97, 79, 17 and 7 pts received ICI in 1L, 2L, 3L and 4L, respectively; 26% pts with ICI in 1L and 2L had ECOG PS 2-3. ORR and mOS are shown in table. Among 106 pts who died, 96 had available death location; of those, 8% received ICI within 30 days of death. Starting ICI within 30 days of death (vs no tx) was associated with higher odds of hospital death (OR 6.05, 95%CI 1.3-27.6). Estimated average ICI cost/pt within 30 days of death was $1400.58. Conclusions: Pts with ECOG PS 2-3 at time of ICI initiation had similar ORR vs ECOG PS < 2 but worse mOS. ICI initiation within 30 days from death was associated with higher likelihood of hospital death. ICI may not circumvent the negative prognostic role of poor PS, so biomarker-based pt selection is critical. Limitations include lack of adjustment for selection bias and other confounders at time of ICI initiation; data validation is ongoing. [Table: see text]

Atezolizumab (atezo) therapy for locally advanced/metastatic urinary tract carcinoma (mUTC) in patients (pts) with poor performance status (PS): Analysis of the prospective global SAUL study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5035-5035
Author(s):  
Daniel Castellano ◽  
Craig Gedye ◽  
Giuseppe Fornarini ◽  
Andre P. Fay ◽  
Jens Voortman ◽  
...  
Keyword(s):  
Performance Status ◽  
Locally Advanced ◽  
Poor Performance ◽  
Poor Performance Status ◽  
World Population ◽  
Dismal Prognosis ◽  
Visceral Metastases ◽  
Baseline Factors ◽  
Poor Outcomes ◽  
Ecog Ps

5035 Background: Pts with PS > 1 have a poor prognosis and are often excluded from clinical trials. The single-arm SAUL study (NCT02928406) evaluated atezo in a ‘real-world’ population. Overall, safety and efficacy were consistent with prior trials. However, ECOG PS 2 pts had worse overall survival (OS) but fewer adverse events (AEs) than ECOG PS 0/1 pts [Sternberg, 2019], likely reflecting shorter treatment duration and warranting exploration. Methods: Pts with mUTC received atezo 1200 mg q3w until loss of clinical benefit or unacceptable toxicity. The primary endpoint was safety. Post hoc analyses compared baseline factors, AEs and efficacy in pts with ECOG PS 2 vs 0/1. In this analysis, AE incidences were restricted to the first 45 days of atezo to adjust for differing treatment exposure. Results: None of the baseline factors explored was significantly associated with worse OS or disease control rate (DCR) in ECOG PS 2 pts. However, pts with visceral metastases and ECOG PS 2 had particularly poor outcomes. Safety appeared similar between subgroups. Conclusions: ECOG PS 2 pts have a dismal prognosis. The higher proportion with poor prognostic factors despite similar age in ECOG PS 2 vs 0/1 pts may suggest that poor PS was related to disease rather than comorbidities. Risk/benefit should be considered especially carefully when treating pts with ECOG PS 2 due to high-burden/visceral disease. Clinical trial information: NCT02928406 . [Table: see text]

Weekly chemotherapy instead of best supportive care alone must be considered for patients of small cell lung cancer with poor performance status.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21102-e21102
Author(s):  
Gunjan Shrivastav ◽  
Alok Gupta ◽  
Neha Sonthwal ◽  
Suhas Kirti Singla ◽  
Tarun Mohindra ◽  
...  
Keyword(s):  
Chemotherapy Regimen ◽  
Performance Status ◽  
Objective Response ◽  
Poor Performance ◽  
Median Number ◽  
Best Supportive Care ◽  
Poor Performance Status ◽  
Weekly Chemotherapy ◽  
Group A ◽  
Group B

e21102 Background: Many patients of Small Cell Lung Cancer (SCLC) present with advanced age & comorbidities. Although chemotherapy may benefit these patients, therapy is denied due to treatment toxicities. We studied tolerability and efficacy of weekly Etoposide with carboplatin in patients unfit for 3-weekly regimen to analyze the hypothesis if small dose weekly chemotherapy can replace the current standard of care of best supportive care (BSC) alone in patients with poor performance status (PS). Methods: We retrospectively studied consecutive patients of SCLC treated between January 2015- December 2017. Based on team’s assessment, patients received either Etoposide100 mg/m2 (Day 1,2,3) + Cisplatin25 mg/m2 (Day 1,2,3) (or Carboplatin AUC5 Day 1) q 21 days OR Etoposide100 mg/m2 + Carboplatin(AUC2)q weekly OR BSC. Responses at 6-9 weeks of therapy and toxicities were studied according to RECIST 1.1 and CTCAEv4 criteria respectively. Results: 66 patients were diagnosed with SCLC. 24 patients received 3-weekly chemotherapy regimen (Group A). Of the 42 unfit patients, 21(50 %) received weekly chemotherapy regimen (Group B). Median age was higher in Group B ( 66 vs 61 yrs ) and Co-morbidities (≥ 2)were also more in Group B, 53 vs 33 %. Furthermore, Group B had more brain metastases (38 vs 21 %) but there was equal distribution of liver metastases and SVCO (4 patients each group). Altogether Group B had worse prognostic patients. In Group A the median number of chemotherapy cycles received were 4.5 (1-8) over a median duration of 3.37 months (0.75 - 6) while in group B the median number of chemotherapy cycles were 2 (1-5) over 1.5 months (0.5 - 3.75). G-CSF was required in 22(92%) in Group A and 15(71%) in Group B. Grade 3-4 toxicity and Febrile neutropenia were seen in 11(46%) and 7(29%) patients in Group A respectively and 8(38.1%) and 7(33%) patients in Group B respectively. Progressive disease was seen in 3(13%) and 6(29%) patients in group A and B respectively. Objective response was seen in 14(59%) and 9(43%) in Group A and B respectively. Clinical benefit rate (CBR) (Objective response + Stable disease) was 75% in Group A and 57% in Group B. Among patients with brain metastasis, CBR was 60% in Group A and 50% in Group B. This was better than most patients that are not offered treatment. Conclusions: Although 3 weekly doublet remains a better regimen, weekly etoposide and platinum is a valid option for patients unfit for standard regimen with no excess toxicity. Clinical benefit is seen irrespective of poor prognostic features.

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