Optimizing Treatment for Elderly Patients With Newly Diagnosed Multiple Myeloma: A Personalized Approach

2016 ◽  
Vol 34 (30) ◽  
pp. 3600-3604 ◽  
Author(s):  
Alessandra Larocca ◽  
Antonio Palumbo
Keyword(s):  
Multiple Myeloma ◽  
Group Performance ◽  
Performance Status ◽  
Relevant Literature ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Phase Iii ◽  
Bone Lesions ◽  
Best Response ◽  
Personalized Approach

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors’ suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice. An 84-year-old woman presented with bone pain and lytic bone lesions in April 2010. Diagnosis of multiple myeloma was based on the presence of an immunoglobulin G lambda serum M protein (4,784 mg/dL) and confirmed by the findings of bone marrow plasma cell infiltration, with t(11;14) chromosomal abnormality detected by fluorescence in situ hybridization analysis. The patient’s medical history was significant for hypertension; she had an Eastern Cooperative Oncology Group performance status of 1, International Staging System (ISS) stage of 1, and Durie–Salmon stage of IIIA. In May 2010, the patient was enrolled in a randomized phase III trial comparing different lenalidomide-based treatments and received induction with lenalidomide plus dexamethasone (nine cycles) followed by lenalidomide maintenance. The patient started treatment with lenalidomide 25 mg per day for 21 days and reduced-dose dexamethasone 20 mg per week per protocol because of age. Induction was well tolerated; no relevant complications occurred, except for grade 1 fatigue and grade 1 diarrhea. Best response was partial response. In March 2011, she started maintenance with lenalidomide 10 mg per day. A dose reduction of lenalidomide 5 mg per day was required because of grade 2 diarrhea. In July 2015, the patient experienced relapse, with painful collapse of L3 vertebral body.

Activity of Eribulin in Patients With Advanced Liposarcoma Demonstrated in a Subgroup Analysis From a Randomized Phase III Study of Eribulin Versus Dacarbazine

2017 ◽  
Vol 35 (30) ◽  
pp. 3433-3439 ◽  
Author(s):  
George D. Demetri ◽  
Patrick Schöffski ◽  
Giovanni Grignani ◽  
Jean-Yves Blay ◽  
Robert G. Maki ◽  
...  
Keyword(s):  
Subgroup Analysis ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Progression Free Survival ◽  
Hazard Ratio ◽  
Phase Iii ◽  
Eribulin Mesylate ◽  
Systemic Treatments ◽  
Phase Iii Study

Purpose A phase III study comparing eribulin with dacarbazine in patients with advanced liposarcoma (LPS) or leiomyosarcoma showed a significant improvement in overall survival (OS) for the eribulin arm, with a manageable toxicity profile. We now report the histology-specific subgroup analysis of the efficacy and safety of eribulin compared with dacarbazine in patients with LPS, an independently randomized stratified subgroup of this phase III trial. Methods Patients ≥ 18 years with advanced or metastatic dedifferentiated, myxoid/round cell, or pleomorphic LPS incurable by surgery or radiotherapy were included. Patients with Eastern Cooperative Oncology Group performance status ≤ 2 and two or more prior systemic treatment regimens, including one with anthracycline, were randomly assigned 1:1 to receive eribulin mesylate (1.4 mg/m2 intravenously on days 1 and 8) or dacarbazine (850, 1,000, or 1,200 mg/m2 intravenously on day 1) every 21 days. OS, progression-free survival (PFS), and safety were analyzed. Results In the LPS subgroup, OS was significantly improved: 15.6 versus 8.4 months (hazard ratio, 0.51; 95% CI, 0.35 to 0.75; P < .001) with eribulin versus dacarbazine, respectively. Longer OS with eribulin was observed in all LPS histologic subtypes and in all geographic regions evaluated. PFS was also improved with eribulin versus dacarbazine (2.9 v 1.7 months, respectively; hazard ratio, 0.52; 95% CI, 0.35 to 0.78; P = .0015). Adverse events were similar between arms. Conclusion In patients with previously treated LPS, eribulin was associated with significantly superior OS and PFS compared with dacarbazine. Eribulin represents an important treatment option for patients with LPS, a sarcoma subtype for which limited effective systemic treatments are available. Further studies are justified to explore the role of eribulin in earlier lines of therapy as well as in combination with other agents.

Radioembolization in Advanced Hepatocellular Carcinoma

2018 ◽  
Vol 36 (19) ◽  
pp. 1898-1901 ◽  
Author(s):  
Ahsun Riaz ◽  
Robert Lewandowski ◽  
Riad Salem
Keyword(s):  
Hepatocellular Carcinoma ◽  
Portal Vein ◽  
Group Performance ◽  
Performance Status ◽  
Relevant Literature ◽  
Eastern Cooperative Oncology Group ◽  
Distant Metastases ◽  
Advanced Hepatocellular Carcinoma ◽  
Vein Thrombosis ◽  
Management Approaches

The Oncology Grand Rounds series is designed to place original reports published in the Journal into clinical context. A case presentation is followed by a description of diagnostic and management challenges, a review of the relevant literature, and a summary of the authors’ suggested management approaches. The goal of this series is to help readers better understand how to apply the results of key studies, including those published in Journal of Clinical Oncology, to patients seen in their own clinical practice. A 68-year-old man with a remote history of alcohol abuse presented with vague abdominal pain. A review of systems suggested the patient had an Eastern Cooperative Oncology Group performance status 1 (restriction of strenuous physical activity). There were no physical examination findings of note. Laboratory studies disclosed Child-Pugh A liver status (no ascites; no encephalopathy; total bilirubin, 1 mg/dL; albumin, 3.5 g/dL; and international normalized rato, 1.2). The alpha-fetoprotein was mildly elevated (19.5 ng/mL). Magnetic resonance imaging with contrast disclosed an infiltrative mass with extensive malignant right and left portal vein thrombosis ( Fig 1A ) with cavernous transformation of the portal vein. The infiltrative mass ( Fig 2A ) was biopsied, revealing hepatocellular carcinoma. No distant metastases were found on a bone scintigraphy or computerized tomography scan. Given these features, this patient was classified as Barcelona Clinic for Liver Cancer stage C. The patient was referred for management of advanced hepatocellular carcinoma.

scholarly journals CyBorD-DARA is potent initial induction for MM and enhances ADCP: initial results of the 16-BCNI-001/CTRIAL-IE 16-02 study

2019 ◽  
Vol 3 (12) ◽  
pp. 1815-1825 ◽  
Author(s):  
M. O’Dwyer ◽  
R. Henderson ◽  
S. D. Naicker ◽  
M. R. Cahill ◽  
P. Murphy ◽  
...  
Keyword(s):  
Partial Response ◽  
Group Performance ◽  
Residual Disease ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Complete Response ◽  
Weekly Schedule ◽  
Intention To Treat ◽  
Good Partial Response

Abstract Daratumumab (DARA) has shown impressive activity in combination with other agents for the treatment of multiple myeloma (MM). We conducted a phase 1b study to assess the safety and preliminary efficacy, as well as potential mechanisms of action, of DARA (16 mg/kg) in combination with a weekly schedule of subcutaneous bortezomib (1.3-1.5 mg/m2), cyclophosphamide (150-300 mg/m2), and dexamethasone (40 mg) (CyBorD DARA) as initial induction before autologous stem cell transplantation (ASCT). Eligible patients were ≤70 years of age with untreated MM requiring treatment and who lacked significant comorbidities. A total of 18 patients were enrolled. Their median age was 56 years (range, 32-66 years), and all patients had Eastern Cooperative Oncology Group performance status ≤1. The International Staging System stages were I, II, and III in 78%, 17%, and 6% of patients, respectively; 28% of patients had high-risk genetic features. There was no dose-limiting toxicity, and the incidence of grade 3 or 4 infection or neutropenia was &lt;10%. On an intention-to-treat basis, 94% achieved ≥very good partial response with ≥complete response in 44% of patients. Among 14 of 15 patients who underwent ASCT and were evaluable for response, all 14 achieved at least very good partial response, with 8 (57%) of 14 achieving complete response. After ASCT, 10 (83%) of 12 patients in whom minimal residual disease analysis was possible were negative at a sensitivity of 10−5 (56% on intention-to-treat/whole study population) according to next-generation sequencing. Flow cytometry analysis of patient samples indicated CyBorD DARA induced activation of macrophage-mediated antibody-dependent cellular phagocytosis. This trial was registered at www.clinicaltrials.gov as #NCT02955810.

Axitinib versus sorafenib as first‑line therapy in patients with metastatic renal cell carcinoma (mRCC).

2013 ◽  
Vol 31 (6_suppl) ◽  
pp. LBA348-LBA348 ◽  
Author(s):  
Thomas E. Hutson ◽  
Jorge Gallardo ◽  
Vladmir Lesovoy ◽  
Salman Al-Shukri ◽  
Viktor Stus ◽  
...  
Keyword(s):  
Primary Endpoint ◽  
Survival Data ◽  
Group Performance ◽  
Performance Status ◽  
Objective Response ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
First Line ◽  
First Line Therapy ◽  
Line Therapy

LBA348 Background: In the phase III AXIS trial, second-line therapy with axitinib resulted in significantly longer progression-free survival (PFS) versus sorafenib for mRCC. We conducted a multicenter, randomized, open-label, phase III trial to compare PFS of axitinib vs sorafenib as first-line therapy. Methods: Patients with untreated, measurable (RECIST v1.0), clear‑cell mRCC and Eastern Cooperative Oncology Group performance status (PS) 0 or 1 were randomized 2:1 to axitinib 5 mg twice daily (BID) or sorafenib 400 mg BID. Randomization was stratified by PS. Primary endpoint was PFS per independent radiology committee. The study had 90% power to detect a 78% PFS improvement from 5.5 mo with sorafenib to 9.8 mo with axitinib, corresponding to a hazard ratio (HR) of 0.561 (overall 1-sided α=0.025). Results: Patients (N=288) were mainly from Eastern Europe (51%), Asia (25%), North America (14%), or South America (10%).Patient baseline characteristics for axitinib (n=192) vs sorafenib (n=96) included: median age, 58y vs 58y; male, 70% vs 77%; white, 71% vs 69%; favorable risk, 49% vs 55%; PS 0, 57% vs 57%; nephrectomy, 85% vs 90%. Median (m) PFS was 10.1 vs 6.5 mo with axitinib vs sorafenib (HR adjusted for PS, 0.767; 95% confidence interval [CI], 0.559–1.053; 1‑sided P=0.0377). In patients with PS 0 and 1, respectively, mPFS with axitinib vs sorafenib was 13.7 vs 6.6 mo (HR, 0.644; 95% CI, 0.419–0.991; 1‑sided P=0.022) and 6.5 vs 6.4 mo (HR, 0.931; 95% CI, 0.585–1.482; 1‑sided P=0.38). Objective response rates (ORRs) with axitinib vs sorafenib were 32.3% vs 14.6% (1‑sided P=0.0006 adjusted for PS). Overall survival data were not mature. All-grade all‑causality adverse events (≥20%) with axitinib vs sorafenib were diarrhea (50% vs 40%), hypertension (49% vs 29%), weight decreased (37% vs 24%), fatigue (33% vs 26%), decreased appetite (29% vs 19%), palmar-plantar erythrodysesthesia (26% vs 39%), dysphonia (23% vs 10%), asthenia (21% vs 16%), and hypothyroidism (21% vs 7%). Conclusions: The study did not achieve its primary endpoint statistically, but axitinib demonstrated numerically longer mPFS and significantly higher ORR vs sorafenib, with an acceptable safety profile, as first-line therapy for mRCC. Clinical trial information: NCT00920816.

LAPACT: An open-label, multicenter phase II trial of nab-paclitaxel (nab-P) plus gemcitabine (Gem) in patients (pts) with locally advanced pancreatic cancer (LAPC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS477-TPS477 ◽  
Author(s):  
Philip Agop Philip ◽  
Jill Lacy ◽  
Scot D. Dowden ◽  
Javier Sastre ◽  
Venu Gopal Bathini ◽  
...  
Keyword(s):  
Group Performance ◽  
Performance Status ◽  
Locally Advanced ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
The United States ◽  
Phase Iii ◽  
Open Label ◽  
Primary Tumors

TPS477 Background: In pts with LAPC, more effective systemic therapies may be associated with improved local control, delay of metastasis, and overall survival (OS). The phase III MPACT trial in pts with metastatic PC demonstrated longer OS (median, 8.7 vs 6.6 mos; HR, 0.72; P < 0.001) and an ≈ 3-fold greater shrinkage of primary tumors with nab-P + Gem vs Gem alone (−22.15% vs −7.02%), raising the possibility of improved local PC control with nab-P + Gem. LAPACT will assess the efficacy and safety of nab-P + Gem in LAPC. Methods: LAPACT will enroll treatment-naive pts (planned n ≈ 110) in the United States, Canada, and Europe with Eastern Cooperative Oncology Group performance status ≤ 1, confirmed unresectable LAPC, no distant metastases, and adequate organ function. Pts with mixed-origin tumors, any other malignancy within 5 years, peripheral neuropathy grade > 1, or clinically significant ascites are ineligible. Pts will receive nab-P 125 mg/m2 + Gem 1000 mg/m2 on days 1, 8, and 15 of each 28-day cycle. Pts without progressive disease (PD) or unacceptable toxicity after 6 cycles will receive investigator’s choice of surgery, chemoradiotherapy, or continued nab-P + Gem. If a major response is observed, surgery may occur prior to completing 6 cycles of nab-P + Gem. The primary endpoint is time to treatment failure (TTF; time from first therapy dose to discontinuation due to PD, start of a new non–protocol-defined anti-cancer therapy, or death). The study design allows for 80% power at a 1-sided α of 0.05 to detect a 30% increase over the 5.1-month median TTF observed for nab-P + Gem in the MPACT study. The secondary endpoints are disease control rate (DCR) after 6 cycles, overall response rate, progression-free survival, OS, safety, and quality of life. The exploratory endpoint is correlation of changes in circulating nucleic acids with PD and treatment response. An interim DCR analysis will occur after all pts have completed 6 cycles of nab-P + Gem, discontinued therapy due to PD, died, or started a new non–protocol-defined therapy before completing 6 cycles of therapy. Enrollment is ongoing (first pt enrolled in April 2015). Clinical trial information: NCT02301143.

Imatinib Mesylate in Patients With Adenoid Cystic Cancers of the Salivary Glands Expressing c-kit: A Princess Margaret Hospital Phase II Consortium Study

2005 ◽  
Vol 23 (3) ◽  
pp. 585-590 ◽  
Author(s):  
Sébastien J. Hotte ◽  
Eric W. Winquist ◽  
Elizabeth Lamont ◽  
Mary MacKenzie ◽  
Everett Vokes ◽  
...  
Keyword(s):  
Phase Ii ◽  
Tyrosine Kinases ◽  
Group Performance ◽  
Lung Metastases ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Evaluation Criteria ◽  
Growth Factor Receptor ◽  
Adenoid Cystic ◽  
Best Response

Purpose This study aimed to assess the antitumor activity of imatinib in adenoid cystic carcinoma (ACC) of the salivary gland expressing c-kit. A high level of c-kit expression has been identified in more than 90% of ACCs. Imatinib specifically inhibits autophosphorylation of the bcr-abl, platelet-derived growth factor receptor beta, and c-kit tyrosine kinases. Patients and Methods In a single-arm, two-stage, phase II clinical trial, adult patients with unresectable or metastatic ACC measurable by Response Evaluation Criteria in Solid Tumors Group criteria and expressing c-kit by immunohistochemistry were treated with imatinib 400 mg orally bid. Response was assessed every 8 weeks. Results Sixteen patients have been enrolled onto the study; 10 were female. Median age was 47 years (range, 31 to 69 years). Median Eastern Cooperative Oncology Group performance status was 1 (range, 0 to 2). Fourteen patients had lung metastases, 14 had prior radiotherapy, and six had prior chemotherapy. Toxicities occurring in at least 50% of patients included fatigue, nausea, vomiting, diarrhea, anorexia, edema, dyspnea, and/or headache, usually of mild to moderate severity. In 15 patients assessable for response, no objective responses have been observed. Nine patients had stable disease as best response. Six patients had progressive disease after two cycles. Conclusion Because of the lack of activity, the study has been stopped after the first stage and additional evaluation of imatinib in this population is not warranted. Overexpression of wild-type c-kit was not sufficient for clinical benefit from imatinib in ACC. Accrual to this study was rapid for a relatively rare cancer, encouraging additional efforts to identify more effective systemic therapy for these patients.

scholarly journals A genomic-clinical nomogram predicting recurrence-free survival for patients diagnosed with hepatocellular carcinoma

PeerJ ◽  
2019 ◽  
Vol 7 ◽  
pp. e7942
Author(s):  
Junjie Kong ◽  
Tao Wang ◽  
Shu Shen ◽  
Zifei Zhang ◽  
Xianwei Yang ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Risk Model ◽  
Cox Regression ◽  
Group Performance ◽  
Performance Status ◽  
Survival Rates ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Recurrence Free Survival ◽  
Free Survival

Liver resection surgery is the most commonly used treatment strategy for patients diagnosed with hepatocellular carcinoma (HCC). However, there is still a chance for recurrence in these patients despite the survival benefits of this procedure. This study aimed to explore recurrence-related genes (RRGs) and establish a genomic-clinical nomogram for predicting postoperative recurrence in HCC patients. A total of 123 differently expressed genes and three RRGs (PZP, SPP2, and PRC1) were identified from online databases via Cox regression and LASSO logistic regression analyses and a gene-based risk model containing RRGs was then established. The Harrell’s concordance index (C-index), receiver operating characteristic (ROC) curves and calibration curves showed that the model performed well. Finally, a genomic-clinical nomogram incorporating the gene-based risk model, AJCC staging system, and Eastern Cooperative Oncology Group performance status was constructed to predict the 1-, 2-, and 3-year recurrence-free survival rates (RFS) for HCC patients. The C-index, ROC analysis, and decision curve analysis were good indicators of the nomogram’s performance. In conclusion, we identified three reliable RRGs associated with the recurrence of cancer and constructed a nomogram that performed well in predicting RFS for HCC patients. These findings could enrich our understanding of the mechanisms for HCC recurrence, help surgeons predict patients’ prognosis, and promote HCC treatment.

scholarly journals Nintedanib Plus Pemetrexed/Cisplatin in Patients With Malignant Pleural Mesothelioma: Phase II Results From the Randomized, Placebo-Controlled LUME-Meso Trial

2017 ◽  
Vol 35 (31) ◽  
pp. 3591-3600 ◽  
Author(s):  
Federica Grosso ◽  
Nicola Steele ◽  
Silvia Novello ◽  
Anna K. Nowak ◽  
Sanjay Popat ◽  
...  
Keyword(s):  
Overall Survival ◽  
Placebo Group ◽  
Phase Ii ◽  
Malignant Pleural Mesothelioma ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Phase Iii ◽  
Pleural Mesothelioma ◽  
Double Blind

Purpose LUME-Meso is a phase II/III randomized, double-blind trial designed to assess efficacy and safety of nintedanib plus chemotherapy as first-line treatment of malignant pleural mesothelioma (MPM). Phase II results are reported here. Patients and Methods Chemotherapy-naïve patients with unresectable, nonsarcomatoid MPM (Eastern Cooperative Oncology Group performance status 0 to 1), stratified by histology (epithelioid or biphasic), were randomly assigned in a 1:1 ratio to up to six cycles of pemetrexed and cisplatin plus nintedanib (200 mg twice daily) or placebo followed by nintedanib plus placebo monotherapy until progression. The primary end point was progression-free survival (PFS). Results Eighty-seven patients were randomly assigned. The median number of pemetrexed and cisplatin cycles was six; the median treatment duration for nintedanib was 7.8 months and 5.3 months for placebo. Primary PFS favored nintedanib (hazard ratio [HR], 0.56; 95% CI, 0.34 to 0.91; P = .017), which was confirmed in updated PFS analyses (HR, 0.54; 95% CI, 0.33 to 0.87; P = .010). A trend toward improved overall survival also favored nintedanib (HR, 0.77; 95% CI, 0.46 to 1.29; P = .319). Benefit was evident in epithelioid histology, with a median overall survival gain of 5.4 months (HR, 0.70; 95% CI, 0.40 to 1.21; P = .197; median [nintedanib v placebo], 20.6 months v 15.2 months) and median PFS gain of 4.0 months (HR, 0.49; 95% CI, 0.30 to 0.82; P = .006; median [nintedanib v placebo], 9.7 v 5.7 months). Neutropenia was the most frequent grade ≥ 3 adverse event (AE; nintedanib 43.2% v placebo 12.2%); rates of febrile neutropenia were low (4.5% in nintedanib group v 0% in placebo group). AEs leading to discontinuation were reported in 6.8% of those receiving nintedanib versus 17.1% of those in the placebo group. Conclusion Addition of nintedanib to pemetrexed plus cisplatin resulted in PFS improvement. AEs were manageable. The clinical benefit was evident in patients with epithelioid histology. The confirmatory phase III part of the study is ongoing.

Changes in patient-reported outcomes in patients diagnosed with and treated for multiple myeloma in the Connect MM registry.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8586-8586 ◽  
Author(s):  
Chris L. Pashos ◽  
Jatin J. Shah ◽  
Howard R. Terebelo ◽  
Brian G. Durie ◽  
Rafat Abonour ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Patient Reported Outcomes ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Staging System ◽  
Ecog Performance Status ◽  
Related Factors ◽  
Patient Reported ◽  
Ecog Ps ◽  
The Impact

8586 Background: Little is known about the impact of treatment on patient-reported outcomes (PROs) and health-related quality of life (HRQoL) in multiple myeloma (MM) patients (pts). The change in PROs of MM pts between baseline and 1 year was assessed relative to their baseline International Staging System (ISS) stage and Eastern Cooperative Oncology Group (ECOG) performance status (PS) score. Methods: Connect MM is a prospective US registry of MM pts initiated in 2009. Clinicians reported pt demographics, ECOG PS score, and ISS stage. PROs were collected at baseline and at 1 year utilizing the Functional Assessment of Cancer Therapy (FACT)-MM, EQ-5D, and Brief Pain Inventory (BPI). Changes in FACT-MM, EQ-5D, and BPI scores were analyzed by ISS stage and ECOG PS score in 636 pts meeting CRAB criteria from 189 centers. Results: Most pts were male (58%) and white (84%). Mean age was 66 years (± 11). Pts were treated in community (81%), academic (17%), or veterans/military (2%) settings. ISS stages of pts were: I (29%), II (35%), and III (35%). ECOG PS scores were 0 (37%), 1 (49%), 2 (11%), and 3 (3%). Improvements in overall HRQoL as shown by the FACT-MM and FACT-General (G) total scores, were observed across all ISS stages (P = 0.03 to < 0.0001) with no significant differences between stages. Improvements in FACT-MM and FACT-G total scores were observed with ECOG PS scores 1–3 (P = 0.03 to 0.005). Pts with poorer ECOG PS scores tended to have greater improvement in EQ-5D domains of mobility, self-care, and usual activities. HRQoL/functional ability improved in 4 of 5 FACT domains (except social/family; all others P < 0.0001), and in 4 of 5 EQ-5D domains (except pain/discomfort; all others, P = 0.01 to < 0.0001). BPI showed that overall average pain improved (P < 0.0005) over 1 year, but statistically significant differences by ISS stage or ECOG PS score were not observed. Conclusions: Connect MM data showed that overall HRQoL of MM pts improved between baseline and 1 year, with a consistent benefit observed across pts with different ISS stages and ECOG PS scores. Additional analysis should examine which disease- and treatment-related factors are associated with these HRQoL improvements.

Cohort compassionate-use program (CUP) and early access program (EAP) with cabazitaxel (Cbz) plus prednisone (P; Cbz + P) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel (D): Analysis by age group.

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 109-109
Author(s):  
Zafar Malik ◽  
Giuseppe di Lorenzo ◽  
Sergio Bracarda ◽  
Alexandros Ardavanis ◽  
Mert Basaran ◽  
...  
Keyword(s):  
Disease Progression ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Age Groups ◽  
Phase Iii ◽  
World Population ◽  
Age Group ◽  
Castration Resistant Prostate Cancer ◽  
Grade 3

109 Background: Cbz + P demonstrated an overall survival benefit vs mitoxantrone + P in pts with mCRPC in the Phase III TROPIC trial. The CUP (CABAZ_C_05005) and EAP (NCT01254279) (both funded by Sanofi) were established to allow access to Cbz ahead of commercial availability. The programs are also evaluating Cbz safety in a real-world population. Data analyzed by age group (≤75 and >75 years) are presented here. Methods: Expected enrolment across both programs is 1,450 pts from 236 centres worldwide. Pts received Cbz 25 mg/m2 IV Q3W + P 10 mg QD until disease progression, death, unacceptable toxicity or physician/pt decision. G-CSF is administered as per ASCO guidelines. Results: As of May 30, 2012, 1,301 pts have enrolled (≤75 years: 1,061 pts [81.6%]; >75 years: 240 pts [18.4%]). Eastern Cooperative Oncology Group performance status and incidence of visceral metastases were generally balanced between treatment groups. The most frequent reasons for discontinuation were disease progression (46.8%) followed by adverse events (AEs; 24.4%) in pts ≤75 years, and AEs (36.4%) followed by disease progression (31.1%) in pts >75 years. Time from initial diagnosis to inclusion was greater in pts >75 years (median 79.66 months) than in pts ≤75 years (median 53.94 months), but time from mCRPC diagnosis to inclusion was approximately equivalent (>75 years: median 22.6 months; ≤75 years: median 20.94 months). G-CSF use was more frequent in pts >75 years (cycle 1: 62.9% of pts) compared with pts ≤75 years (cycle 1: 52.2% of pts). AEs of clinical concern were more frequent in the older age group (Grade ≥3 AEs: >75 years 64.2%; ≤75 years 54.8%). Grade ≥3 neutropenia was observed in 25.8% of pts >75 years and in 17.0% of pts ≤75 years. Conclusions: We observed several differences between age groups in baseline and on-treatment parameters, suggesting differences in the natural history of mCRPC (faster disease progression in pts ≤75 years than in pts >75 years) and secondary to treatment (AEs more frequent in pts >75 years compared with pts ≤75 years). Clinical trial information: NCT01254279.

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