Poor Performance Status Patients Research Articles

MTE27.01 Treatment of Lung Cancer Patients with Poor Performance Status

MTE27.01 Treatment of Lung Cancer Patients with Poor Performance Status

P3.02c-097 Nivolumab in Elderly or Poor Performance Status Patients with Advanced Non-Small Cell Lung Cancer: Topic: IT Clinical

Nivolumab showed durable antitumor activity and survival benefit in previously treated patients with advanced non-small cell lung cancer (NSCLC). The aim of this study was to evaluate the efficacy and safety of nivolumab in elderly (≥75 year old) or poor performance status (PS; ≥2) patients with NSCLC, most of who have been excluded from clinical trials. This was a retrospective cohort study investigating the outcome of patients with advanced or post-operative recurrence NSCLC who received nivolumab from January to April 2016 in the National Cancer Center Hospital. Patient characteristics, the efficacy of nivolumab, survival, and adverse events were analyzed. Immunohistochemical (IHC) expression of programmed cell death ligand 1 (PD-L1) in pretreatment tissue (10 biopsy and 3 operation specimens) was assessed using the rabbit monoclonal PD-L1 antibody (clone 28-8; Abcam). Staining of ≥1% of tumor cells was considered as the cut-off value of positive PD-L1 expression. A total of 20 patients, including 10 elderly patients with non-squamous NSCLC and 10 poor PS patients (7 with non-squamous and 3 with squamous NSCLC), received nivolumab. Objective responses were observed in 6 patients: 4 (40%) elderly and 2 (20%) poor PS patients. The median progression-free survival was 2.8 months and 1.7 months in the elderly and poor PS groups, respectively. Of 13 cases with quantifiable IHC results, 10 cases were positive for PD-L1. PD-L1 expression was not predictive of a response, which occurred in 4 of 10 (40%) patients with PD-L1-postive tumors, 1 of 3 (33%) patients with PD-L1-negative tumors, and 1 of 7 (14%) patients with an unknown PD-L1 status (p = 0.52). Treatment-related adverse events led to discontinuation of nivolumab in 6 patients (1 elderly and 5 poor PS patients). Nivolumab had a clinically meaningful response for elderly or poor PS advanced NSCLC patients, but toxicity led to the discontinuation of nivolumab.

Treatment of Lung Cancer Patients With Actionable Mutations in the Intensive Care Unit

BackgroundPatients with advanced-stage non–small-cell lung cancer (NSCLC) have high mortality rates in the intensive care unit (ICU). Although the benefit of chemotherapy for hematologic malignancies in the ICU has previously been explored, few data exist regarding the use of targeted therapy for NSCLC in such settings. The primary objective of the present study was to report our experience with the use of targeted therapy in patients with NSCLC in the ICU. Materials and MethodsWe performed a single-institution, retrospective medical record review. The eligibility criteria included patients with NSCLC with targetable mutations who had received tyrosine kinase inhibitors (TKIs) in the ICU. Cases were identified by queries of our institution's information warehouse database and pharmacy dispensary records from 2010 to 2015. ResultsAll 9 patients who had received TKIs in the ICU had acute respiratory failure. Three patients were successfully extubated after initiating TKI therapy, although 1 required later tracheostomy. TKI therapy stabilized another patient's refractory disseminated intravascular coagulation. The remaining 5 patients showed no measurable clinical improvement and were transitioned to comfort care. The overall ICU mortality rate was 56%. ConclusionPatients with metastatic NSCLC requiring mechanical ventilation have high mortality rates. Cytotoxic chemotherapy is generally contraindicated for poor performance status patients. However, targeted TKI therapy should be considered, given its proven efficacy and few systemic side effects. We recommend the empiric use of targeted therapy for NSCLC patients with suspected and/or known actionable mutations presenting with multifactorial respiratory failure to the ICU, with aggressive determination of the mutation status if not known.

Stereotactic Radiosurgery for Poor Performance Status Patients

Patients with poor performance status (PS), usually defined as a Karnofsky Performance Status of 60 or less, were not eligible for randomized stereotactic radiosurgery (SRS) studies, and many guidelines suggest that whole-brain radiation therapy (WBRT) is the most appropriate treatment for poor PS patients. In this retrospective review of our SRS database, we identified 36 patients with PS of 60 or less treated with SRS for central nervous system (CNS) metastatic disease. PS, as defined by the Karnofsky Performance Status, was 60 (27 patients), 50 (8 patients), or 40 (1 patient). The median number of CNS lesions treated was3. Median overall survival (OS) was 7.2months (range, 0.73-25.6months).Fifteen patients (41%) were alive at 6months, and 6 patients (16.6%) were alive at 1year. There was no difference in OS in patients who underwent previous WBRT. There were no local failures or cases of radiation toxicity. Distant CNS failures were seen in 9 patients (25%). Our patients with poor PS had reasonable median OS and relatively low distant CNS failure rates. Patients in this patient population may be ideal candidates for SRS compared with WBRT given the low incidence of distant failure over their remaining lives and the favorable logistics of single-fraction treatment for these patients with debility and their caregivers.

Neoadjuvant nab-paclitaxel and gemcitabine (AG) in borderline resectable (BR) or unresectable (UR) locally advanced pancreatic adenocarcinoma (LAPC) in patients ineligible for FOLFIRINOX.

328 Background: AG is superior to gemcitabine in patients with advanced pancreas cancer. There are limited data on the use of AG in BR or UR LAPC. Although FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) is an option for such patients, many are not eligible due to age, poor performance status (PS) or comorbidities. Herein, we report our experience with neoadjuvant AG for BR/UR LAPC in patients ineligible for FOLFIRINOX. Methods: In this retrospective series, we included patients with BR/UR LAPC who received neoadjuvant AG. The treatment algorithm included AG for 3-4 months followed by radiation, then re-evaluation for surgery. The published AG regimen doses were modified based on patient tolerance. The primary outcome measure was R0 resection rate. Secondary outcomes were response rate, tolerability, and overall survival (OS). Results: Between 10/2013-9/2015, 20 patients (14 BR, 6 UR) at two institutions were treated with this approach. Median age was 69 years (range 44-90); 11/20 were female; PS ranged from 0-3; 14 patients have completed therapy and 6 remain on treatment. Five were converted to resectability by imaging and subsequently underwent operation; 4 had R0 resections (29% of patients who have finished therapy). To date, 6 patients died from progressive disease (PD), 2 are alive with PD and 12 remain alive on therapy or surveillance. All patients who achieved R0 resections are alive and disease free. The best response to AG was a partial response in 4 patients (20%), stable disease in 11, and progression in 2 with 3 patients still pending re-evaluation. Mean dose intensity was 77% for AG. Toxicities were similar to the published AG regimen. Conclusions: In this small series, both the R0 resection rate and the response rate were at least 20%, despite frequent dose reductions and relatively low dose intensity. Elderly and/or poor PS patients with LAPC have been historically excluded from curative-intent strategies. Our data suggest that these patients may now have a possibility for cure with the use of neoadjuvant AG.

Effects of Obesity on the Efficacy and Toxicity of Induction Chemotherapy in Adult Acute Lymphoblastic Leukemia (ALL)

▪BackgroundThe efficacy and toxicity of induction regimens for acute lymphoblastic leukemia (ALL) are affected by numerous patient and regimen specific variables including age, performance status, cytogenetics, comorbidities, and the selection and dosing of chemotherapeutic agents. Notably, the incidence of leukemia and the ability to achieve remission have been shown to be affected by obesity.1,2 Although there is a lack of data in obese adults with ALL, previous studies have confirmed the poor prognostic implications of obesity in pediatric patients.3 Current practice with regard to chemotherapy dosing in obese patients is dependent on the American Society of Clinical Oncology (ASCO) guidelines, which recommend that chemotherapy should be dosed on actual body weight, regardless of obesity status.4 With the lack of data in obese adults with ALL, it has been postulated that empirically reducing chemotherapy doses may worsen their prognosis. This provided the rationale for this investigation into the effect of obesity on the efficacy and toxicity of induction chemotherapy in adults with ALL.MethodsThe primary objective of this study was to evaluate complete remission (CR) rate to initial induction chemotherapy of obese patients (defined as actual body weight (ABW) > 130% of ideal body weight (IBW)), compared to that of non-obese patients. Secondary objectives included overall survival (OS), relapse free survival (RFS), time to platelet and absolute neutrophil count (ANC) recovery, and grade 3/4 non-hematologic toxicities as graded by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). OS and RFS were estimated by the Kaplan-Meier method, with differences across groups accessed via the logrank test. The incidence of CR was estimated by the cumulative incidence method for competing risks, with differences across groups accessed via Gray's test. Death was considered a competing risk for CR. This retrospective chart review included patients with ALL who received initial induction chemotherapy between January 1, 2003, and December 31, 2013, at Memorial Sloan Kettering Cancer Center (MSKCC). Patients included were > 18 years old, newly diagnosed with ALL who were chemotherapy-naïve for treatment of ALL.ResultsSeventy-two patients were identified during the specified period with a median age at diagnosis for all patients of 46 years (18-86). Patients were primarily excluded as chemotherapy was initiated prior to establishing care with MSKCC. A majority of patients received multi-agent chemotherapy with ALL2, L-20, NY-II, ECOG2993, and CALGB 10403 with a smaller subset of patients of older age or poor performance status treated with vincristine and steroids. Twenty-three patients were identified as being obese with a median of 154% of their IBW. The median % of IBW among the non-obese patients (49 patients) was 115%. All patients received chemotherapy based on body surface area (BSA) calculated on total body weight.All patients in the obese group and 96% of non-obese patients experienced at least one grade 3 or 4 non-hematologic toxicity. Time to ANC recovery (26 days vs. 31 days, for obese and non-obese patients respectively) and platelet recovery (29 days vs. 35 days, respectively) were not different between groups.There was no difference in the cumulative incidence of CR among obese and non-obese patients (p=0.477), with a 1 year incidence of 96% in both groups. RFS was similar among obese and non-obese patients (p=0.203, 36.4% and 52.9% respectively at 3 years). Similarly, there was no significant difference in OS between obese and non-obese patients (p=0.161, 45.5% and 57.1% respectively at 3 years). Univariate analyses demonstrated that there was no significant effect of intensity of regimen utilized or baseline cytogenetics on relapse free survival or overall survival.ConclusionThe findings of this retrospective chart review are consistent with current ASCO guidelines for dosing in obese patients. As there were no differences noted in efficacy or safety between obese and non-obese patients in our study, it remains appropriate to continue dosing obese patients based on actual body weight. Further prospective evaluations are necessary to confirm these findings.

Poor performance status (PS) is an indication for an aggressive approach to neoadjuvant chemotherapy in patients with advanced epithelial ovarian cancer (EOC)

BackgroundSome guidelines suggest that poor performance status (PS) is a contraindication to 1st line chemotherapy. Poor PS is a known adverse prognostic factor in advanced epithelial ovarian cancer (EOC). We show in this retrospective analysis that 1st line chemotherapy in this patient group is not only safe but is associated with good outcomes. Patients and methodsA retrospective review of 114 patients with stage III/IV EOC, who presented with a PS ≥3 at diagnosis and treated as inpatients with upfront platinum-based chemotherapy between 2000 and 2013, at the Royal Marsden Hospital, was conducted. The association between clinical parameters and the likelihood of completion of chemotherapy and overall survival (OS) was assessed. Results66% of patients completed ≥6cycles of platinum-based chemotherapy. Prognostic factors for completion of chemotherapy were improvement of PS during hospital stay (p<0.001) and doublet-chemotherapy with carboplatin/paclitaxel compared to single-agent carboplatin (p=0.004). A negative trend for completion of treatment was seen for patients with low albumin (<25g/l) and low CA125 levels at baseline. The median OS for all patients was 13.1months (95% CI: 10.4–15.8) and 21.2months (95% CI: 16.5–25.8) for those who completed 6cycles of chemotherapy. ConclusionUpfront platinum-based chemotherapy is feasible, beneficial and tolerable for the majority of patients with advanced EOC and poor PS. Guidelines suggesting that best supportive care is the preferred option for poor PS patients with solid tumours should be revised to exclude those with advanced EOC. An aggressive approach utilising neoadjuvant carboplatin plus paclitaxel should be regarded as standard of care.

Patients of all ages with advanced non-small cell lung cancer are not receiving chemotherapy.

Patients of all ages with advanced non-small cell lung cancer are not receiving chemotherapy.

Endosonography-related mortality and morbidity for pulmonary indications: a nationwide survey in the Netherlands

Endosonography is being implemented rapidly in pulmonary medicine for the diagnosis and staging of lung cancer, the assessment of sarcoidosis, and the assessment of mediastinal lesions. Although serious adverse events (SAEs) have been described, safety data outside cohort studies are scarce. To assess the SAE and mortality rate of EUS-guided FNA (EUS-FNA) and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) for mediastinal and/or hilar analysis. Nationwide, retrospective survey by using questionnaires. All hospitals in the Netherlands. All patients undergoing EUS-FNA and EBUS-TBNA for intrathoracic analysis in the period 1999 to 2011. EUS-FNA and EBUS-TBNA. Occurrence of fatal outcomes and SAEs. Detailed information was obtained for each reported case, and all cases were reviewed independently by 2 investigators, including identification of risk factors. All 89 hospitals (100%) responded. An estimated 14,075 EUS-FNA and 2675 EBUS procedures were performed. Seven patients died after endosonography (5 EUS-FNA, 2 EBUS [mortality rate 0.04%]). All fatalities occurred in patients of poor performance status (American Society of Anesthesiologists Physical Status Classification System score of III/IV). Twenty-five SAEs were reported (22 EUS-FNA, 3 EBUS [SAE rate of 0.15%; EUS-FNA 0.16%, EBUS 0.11%]). SAEs were mostly (64%) of infectious origin. No specific risk factors for infectious adverse events could be identified. Retrospective study, possible recall bias, overrepresentation of EUS-FNA cases. Endosonography appears to be a safe technique for the analysis of mediastinal and/or hilar lesions. Poor performance status is a risk factor for fatal outcomes. Mediastinitis and/or mediastinal abscess formation is rare but is a potential and dangerous adverse event of endosonography.

Clinical characteristics of pneumonia in bedridden patients receiving home care: a 3-year prospective observational study.

The aim of the study was to describe the epidemiology, clinical features, antimicrobial treatment, and outcomes of bedridden pneumonia patients receiving home healthcare. A 3-year prospective observational study of poor performance status (PS) 3-4 patients receiving long-term home healthcare and hospitalized at a single center with pneumonia between October 2010 and September 2013 was conducted, and their clinical characteristics were compared with non-bedridden community-acquired pneumonia (CAP) patients. A total of 131 CAP patients with PS 3-4, and 400 CAP patients with PS 0-2 were evaluated. The PS 3-4 patients were older, and exhibited a higher frequency of underlying diseases. Aspiration was thought to be associated with pneumonia in 77.1% of the PS 3-4 patients. Streptococcus pneumoniae was the leading pathogen in both groups, whereas the frequency of streptococci and polymicrobial infections was higher in the PS 3-4 group. The incidence of multidrug-resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa was lower than in previous healthcare-associated pneumonia reports. The in-hospital mortality and recurrence rates were significantly higher in the PS 3-4 group than in the good PS group (17.6% vs. 6.0%, p<0.001 and 15.3% vs. 7.5%, p=0.008, respectively). The clinical characteristics of pneumonia in poor PS patients were similar to healthcare-associated pneumonia (HCAP), except for the frequency of drug-resistant pathogens. Hence, it might be beneficial to categorize pneumonia in home residents with poor PS separately from pneumonia in CAP patients who were previously healthy or experienced mild comorbidities.

Assessing functional status and the survival benefit of chemotherapy for advanced non-small cell lung cancer using administrative claims data

ObjectivesBorderline or poor performance status (PS) patients comprise a significant proportion of those diagnosed with advanced non-small cell lung cancer (AdvNSCLC), but are often excluded from clinical trials. It is difficult to draw conclusions about the benefit of therapy in borderline PS patients due to lack of reliable PS assessments, and small clinical trial samples. Retrospective population-based secondary analyses may allow investigators to study under-represented populations in clinical trials.We hypothesized that patients with poor functional status derive benefit from chemotherapy compared good functional status, but that the magnitude of the benefit is lower compared to patients with good functional status. By utilizing a “disability status” (DS) measure as a proxy for PS, we offer a reliable mechanism for patient stratification that can be implemented in administrative claims data. MethodsMedicare beneficiaries diagnosed with AdvNSCLC between 2001 and 2005 were selected from the Surveillance, Epidemiology and End Results database linked to Medicare claims. Disability status, a previously developed and validated claims-based proxy for baseline PS, was implemented. Patients were assigned to good versus poor DS. Cox proportional hazard models were used to examine the differential effects of chemotherapy for the two DS groups on all-cause mortality, controlling for tumor and patient characteristics. ResultsMost patients in the cohort (n=21,019) were ≥75 years of age (59%), and non-Hispanic white (85%); 91% were assigned to good DS; 38% received chemotherapy. Chemotherapy had a strong protective effect among good DS patients (hazard ratio, 0.43; CI 0.42–0.45; p<0.001), with a slightly smaller effect for poor DS (hazard ratio, 0.50; CI 0.44–0.57). ConclusionsChemotherapy improves survival for advanced NSCLC patients with poor DS but to a lower magnitude than for good DS patients. The DS measure opens the door to assess outcomes for cancer patients with poor functional status using insurance claims data.

O3-3-6 - A Phase II Study of Pemetrexed in Ps 2 Patients with Advanced Egfr Wild-Type Non-Squamous Non-Small Cell Lung Cancer

Background: There is no standard systemic chemotherapy in performance status (PS) 2 patients with non-small cell lung cancer (NSCLC). In poor PS patients harboring epidermal growth factor receptor (EGFR) gene sensitive mutations, gefitinib is preferentially administered. However, cytotoxic chemotherapies still must be adopted in PS 2 patients without EGFR mutations. PS 2 patients are a heterogeneous population, and carboplatin-based combination regimens are not always tolerable.Methods: Chemotherapy-naive PS (ECOG) 2 patients with advanced NSCLC without EGFR mutations or unknown EGFR mutation status were eligible. The patients received pemetrexed (PEM) monotherapy 500 mg/m2 tri-weekly until progression. The primary endpoint was median progression-free survival (PFS), and expected median PFS was determined as 4.0 months.Results: Between September 2009 and April 2013, twenty-eight patients were enrolled. Median age was 74 (range, 59-89) and 15 (54%) of 28 were older than 75. 19 (68%) of 28 were ever smoker, and 18 (64%) had pulmonary emphysema. 16 (57%) had comorbidities such as hypertension, heart disease and/or diabetes. In 26 eligible and assessable patients, the overall response rate, disease control rate, median PFS, and median overall survival were 11.5%, 53.8%, 3.0 (95% confidence interval [CI], 1.9-5.7) months and 9.5 (95%CI, 3.3-12.5) months, respectively. Median administered course number was 3 (range, 1-14). Common (≥10%) grade 3/4 toxicity included 7 (27%) neutropenia, 7 (27%) leucopenia, 4 (15%) fatigue, and 3 (12%) thrombocytopenia. Febrile neutropenia and interstitial lung disease were not observed. There were no treatment-related deaths.Conclusions: Although our study failed to meet expected PFS, PEM monotherapy demonstrated moderate efficacy and good safety even in PS 2 patients. PEM monotherapy may be a treatment option in frail PS 2 patients without indication of carboplatin-based combination therapies, if the patient is EGFR wild-type.

Treating glioblastoma patients with poor performance status: where do we go from here?

Approximately one third of all glioblastoma patients exhibit an impaired functional status in the perioperative setting. Their optimal management is difficult to define. The only available prospective study in poor performance status (PS) patients has been performed in elderly patients (≥ 70 years). In this population, treatment with temozolomide was shown to be safe and to be associated with a clinically significant improvement of PS in one third of patients. In young patients (<70 years), daily clinical experience and retrospective data show that some patients can benefit from temozolomide radiochemotherapy, abbreviated radiation courses, upfront chemotherapy or early use of bevacizumab. However, prospective studies are needed to correctly evaluate these strategies, namely their impact on functional status and quality of life.

Combining targeted agents and hypo- and hyper-fractionated radiotherapy in NSCLC.

Radical radiotherapy remains the cornerstone of treatment for patients with unresectable locally advanced non small cell lung cancer (NSCLC) either as single modality treatment for poor performance status patients or with sequential or concomitant chemotherapy for good performance status patients. Advances in understanding of tumour molecular biology, targeted drug development and experiences of novel agents in the advanced disease setting have brought targeted agents into the NSCLC clinic. In parallel experience using modified accelerated fractionation schedules in locally advanced disease have demonstrated improved outcomes compared to conventional fractionation in the single modality and sequential chemo-radiotherapy settings. Early studies of targeted agents combined with (chemo-) radiotherapy in locally advanced disease in different clinical settings are discussed below and important areas for future studies are high-lighted.

183 Treating extensive stage small cell lung carcinoma in poor performance status patients – is a high 30 day mortality rate justifiable?

183 Treating extensive stage small cell lung carcinoma in poor performance status patients – is a high 30 day mortality rate justifiable?

Treatment outcomes in patients with multiple brain metastases: A prospective randomized study

Context: There is controversy regarding the radiotherapeutic dose fractionation in brain metastases (bm). Aims: The aim of this study is to analyze the treatment outcomes in patients with multiple bm. Settings and Design: Prospective, randomized study. Subjects and Methods: Patients with multiple bm with Eastern Cooperative Oncology Group performance status ≤2 were included. In arm-A patient received whole brain radiotherapy (WBRT) 30 GY in 10# over 2 weeks and in arm-B patients received 20 GY in 5# over 1 week. Assessment of improvement in clinical symptoms was done using Barthel's adjusted daily live (ADL) score. Assessment of radiological response was done using magnetic resonance imaging scan of brain after 3 months of completion of external beam radiation therapy. Acute radiation toxicity was assessed using Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer acute radiation morbidity scoring. Statistical Analysis Used: Chi-square test was used to compare categorical variables between groups. Overall survival was computed by Kaplan-Meier survival analysis and Log-Rank test used for comparison of survival plots. For change in quality-of-life during treatment and follow-up, repeated measures ANOVA were used. Results: In both arms, there was a significant improvement in ADL score after treatment, but when two arms were compared, no significant difference was found between the two treatment arms. There was no statistically significant difference in response or morbidity between the two treatment arms. Median survival was 29 weeks in arm-A compared to 25.86 weeks in patients arm-B. Kaplan-Meier Survival curve analysis shows no significant difference in survival between the two arms. Conclusions: 20 GY in 5 fractions is equally effective with that of the 30 GY in 10 fractions for WBRT in bm. In the palliative setting short duration of treatment with minimum discomfort to the patient is desirable. Hence, we can opt for 20 GY in 5 fractions in poor performance status patients and 30 GY in 10 fractions in patients with good performance status.

Salvage Treatment with Low-Dose Weekly Paclitaxel in Elderly or Poor Performance Status Patients with Metastatic Urothelial Carcinoma

Salvage Treatment with Low-Dose Weekly Paclitaxel in Elderly or Poor Performance Status Patients with Metastatic Urothelial Carcinoma

P59 The Characterisation of Cough in Lung Cancer

IntroductionCough in lung cancer (LC) is a distressing symptom with a significant impact on quality of life (QoL), and no effective therapies. Little data is available defining the proportion of...

A phase II trial of frontline capecitabine and bevacizumab in poor performance status and/or elderly patients with metastatic colorectal cancer

This study aims to determine the efficacy and tolerability of capecitabine (CAP) plus bevacizumab (BEV) as treatment for frontline metastatic colorectal cancer (mCRC) in frail and/or elderly patients. This was an open label, multi-site, single arm, phase II study in frontline mCRC. In this study, patients (pts) who were frail (ECOG 2) or older patients with ECOG 1 performance status (PS) received CAP (1000 mg/m(2) bid, 14 days of every 21 days) plus BEV (7.5mg/kg iv once every 21 days). The primary objective was progression free survival (PFS). Secondary objectives were overall response rate (ORR) and toxicity. In terms of patients: 50 were enrolled; 5 withdrew consent prior to treatment; 45 were treated, and 41 were evaluable. The mean age was 75.9 (range 54-93) and 62% had an ECOG 2 PS. The median PFS was 6.87 months (95% CI, 5.1-11.5 months) and median overall survival was 12.7 months (95% CI, 6.9-12.7 months). The most common grades 3-4 toxicities were: diarrhea (17.8%), fatigue (13.3%), hand-foot syndrome (13.3%), dehydration (8.9%), hypertension (6.7%) and vomiting (6.7%). The results of this trial support the use of CAP plus BEV as first-line treatment for frail/elderly patients with metastatic CRC. The ORR (40%) is comparable to pooled data in elderly on fluorouracil (5-FU)+BEV. The median PFS (7.2 months) in this study is slightly lower than that seen with 5-FU+BEV but this study had a high percentage of ECOG PS 2 patients. Side effects were manageable with no new safety signals.

Is there a role for chemotherapy in metastatic colorectal cancer patients with a poor performance status?

e14583 Background: The management of patients with poor performance status (PS) remains challenging in the absence of data on optimal treatment. Here we assessed the treatment and outcomes of patients with metastatic colorectal cancer (mCRC) with poor Eastern Cooperative Oncology Group (ECOG) PS (≥ 2) in routine clinical care. Methods: Analysis of patients prospectively entered onto the TRACC (Treatment of Recurrent and Advanced Colorectal Cancer) database, a clinician-designed initiative to collect comprehensive data on consecutive patients with mCRC from sites across Australia. Data collection commenced in July 2009 and is ongoing at 14 participating public and private centers. Results: Of the 864 patients entered, 161 (18.6%) had an ECOG PS ≥ 2. In total, 95 (11.0%) were PS 2, 54 (6.3%) PS 3 and 12 (1.4%) PS 4. Chemotherapy was administered to 65 (68.4%) PS 2 and 17 (31.5%) PS 3 patients, with none of the PS 4 patients being treated. Overall, poor PS patients were significantly less likely to receive any chemotherapy compared to their good PS (PS 0-1) counterparts (51.6% versus 86.8%, p&lt;0.0001) and, when chemotherapy was given, significantly less likely to receive combination chemotherapy (67.5% vs 81.1%, p=0.0057) or bevacizumab (31.3% vs 55.8%, p&lt;0.0001). Overall survival (OS) was reduced with declining PS, with medians of 28.7, 8.9, 3.5 and 0.8 months for PS 0-1, 2, 3 and 4 patients respectively (p&lt;0.0001). Poor PS patients treated with chemotherapy had a better OS outcome (9.0 vs 3.5 months for untreated patients, p&lt;0.0001). At one and two years, 24 (28.9%) and 7 (8.4%) treated poor PS patients were alive. Conclusions: In routine practice many patients with a poor PS, particularly those that are PS 2, receive active treatment. Although overall survival for poor PS patients is poor, some patients appear to benefit from treatment. Further data analysis, particularly to define subsets that may benefit most from treatment, is planned as further sites around Australia contribute data to the project.