Thalidomide-dexamethasone compared with melphalan-prednisolone in elderly patients with multiple myeloma

Blood ◽  
2009 ◽  
Vol 113 (15) ◽  
pp. 3435-3442 ◽  
Author(s):  
Heinz Ludwig ◽  
Roman Hajek ◽  
Elena Tóthová ◽  
Johannes Drach ◽  
Zdenek Adam ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Elderly Patients ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Interferon Α ◽  
Poor Performance Status ◽  
Time To Progression ◽  
Free Survival ◽  
Odd Cycles

AbstractWe compared thalidomide-dexamethasone (TD) with melphalan-prednisolone (MP) in 289 elderly patients with multiple myeloma (MM). Patients received either thalidomide 200 mg plus dexamethasone 40 mg, days 1 to 4 and 15 to 18 on even cycles and days 1 to 4 on odd cycles, during a 28-day cycle or to melphalan 0.25 mg/kg and prednisolone 2 mg/kg orally on days 1 to 4 during a 28- to 42-day cycle. Patients achieving stable disease or better were randomly assigned to maintenance therapy with either thalidomide 100 mg daily and 3 MU interferon α-2b thrice weekly or to 3 MU interferon α-2b thrice weekly only. TD resulted in a higher proportion of complete and very good remissions (26% vs 13%; P = .006) and overall responses (68% vs 50%; P = .002) compared with MP. Time to progression (21.2 vs 29.1 months; P = .2), and progression-free survival was similar (16.7 vs 20.7 months; P = .1), but overall survival was significantly shorter in the TD group (41.5 vs 49.4 months; P = .024). Toxicity was higher with TD, particularly in patients older than 75 years with poor performance status. The study was registered at ClinicalTrials.gov as NCT00205751.

Attenuated regimen of biweekly gemcitabine/nab-paclitaxel in patients aged > 65 years with advanced pancreatic cancer (APC).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 705-705
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  
Keyword(s):  
Performance Status ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Weekly Schedule ◽  
Free Survival ◽  
Kaplan Meier ◽  
Ecog Ps ◽  
Dose Reductions

705 Background: Treatment with gemcitabine/nab-paclitaxel confers a survival benefit over gemcitabine monotherapy in APC. However, such treatment can be associated with significant toxicities especially in older patients and carries practical disadvantages related to a weekly schedule along with financial cost. We retrospectively analyzed patients > 65 years of age with APC who received a modified biweekly regimen of gemcitabine/nab-paclitaxel to evaluate efficacy and toxicity. Methods: Patients aged > 65 years with chemo-naive APC and ECOG PS < 2 were studied. Patients were treated with a modified regimen of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 every 2 weeks on days 1 and 15 of a 28-day cycle. Patients were evaluated for progression-free survival (PFS) and overall survival (OS) with analyses performed using Kaplan-Meier method. Adverse events were recorded on the day of chemotherapy. CA19-9 was measured every cycle and restaging scans were performed every two cycles. Results: Seventy-three patients (median age: 73; range: 66 - 93) were treated with biweekly gemcitabine/nab-paclitaxel as first-line treatment. The median OS and PFS were 9.1 months and 4.8 months respectively. 66% of patients received growth factor support based on ASCO guidelines and no patients developed neutropenic fever. The incidence of grade > 3 toxicity for neutropenia, anemia, thrombocytopenia, and neurotoxicity were 2%, 7%, 3%, and 5% respectively. Dose reductions of gemcitabine/nab-paclitaxel were required in 10% and 4% patients respectively. Conclusions: In patients > 65 years of age with APC, a modified regimen of biweekly gemcitabine/nab-paclitaxel was found to be effective when compared with historical control from the MPACT study. This regimen allowed for less dose reductions, reduced healthcare costs from additional appointments, travel-related cost, as well as favorable side effect profile while maintaining efficacy. Though retrospective in nature, this study underlines the need for further investigation, particularly in elderly patients with APC and poor performance status. Better tolerability may allow for combination with a third agent, such as a targeted or immunotherapy.

First-line osimertinib in EGFR mutation-positive non-small cell lung cancer patients with poor performance status

2021 ◽  
Author(s):  
Shigemasa Takamizawa ◽  
Yusuke Okuma ◽  
Yasuhiro Kato ◽  
Taiki Hakozaki ◽  
Shingo Kitagawa ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Kinase Inhibitors ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
First Line ◽  
Free Survival ◽  
Lung Cancer Patients ◽  
Egfr Tyrosine Kinase Inhibitors

Background: The efficacy of osimertinib as a first-line treatment for patients with poor performance status (PS) remains unclear. Patients & methods: This multicenter retrospective study evaluated patients treated with osimertinib between 2018 and 2020, with PS 2–4. Results: Among 36 patients with PS 2, the median progression-free survival (PFS), 1-year PFS, median overall survival (OS) and 1-year OS were 14.5 months, 65.4%, 18.1 months and 72.7%, respectively. Among 20 patients with PS 3–4, the median PFS, 1-year PFS, median OS and 1-year OS were 3.0 months, 27.1%, 5.0 months and 46.1%, respectively. Conclusion: Osimertinib was not as efficacious as other EGFR-tyrosine kinase inhibitors.

221 Poor performance status negatively affects survival benefit of immunotherapy in non-small cell lung cancer

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A240-A240
Author(s):  
Hameem Kawsar ◽  
Pramod Gaudel ◽  
Nahid Suleiman ◽  
Mohammed Al-Jumayli ◽  
Chao Huang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Free Survival ◽  
Good Performance Status ◽  
Ecog Ps

BackgroundImmunotherapy has shown survival benefit as both frontline and subsequent therapy in multiple cancers. However, its efficacy in patients with poor performance status is unknown since they are excluded from the clinical trials. We conducted a retrospective study to investigate the effect of poor performance status (PS) on survival in patients with non-small cell lung cancer (NSCLC) who received immunotherapy as a subsequent line of treatment.MethodsWe reviewed the medical records of 341 patients with NSCLC receiving immunotherapy as between July 2013 and June 2018. Progression-free survival and overall survival was calculated using Kaplan-Meier curve.ResultsThe average age of patients was 66 years (range: 39–90 years), with a male predominance (57%). Majority of the patients were Caucasian (87%), followed by African-American (12%), and Asian (1%). Most of the patients were former smoker (72%), followed by current smoker (19%) and never smoker (7%). Adenocarcinoma and squamous cell carcinoma was diagnosed in 206 (60%) patients and 112 (33%) patients, respectively. The ECOG-PS was 0, 1, 2 and 3 in 46 (13%), 175 (51%), 86 (25%) and 34 (10%), respectively. Four different immunotherapies were used, namely atezolizumab in 10 (3%), durvalumab in 34 (10%), nivolumab in 152 (44%) and pembrolizumab in 144 (42%) patients. Average number of cycles of atezolizumab received by the patient was 6 (range 2–22 cycles), durvalumab 15 (range 1–29 cycles), nivolumab 11 (range 1–112 cycles), and pembrolizumab 12 (range 1–52 cycles). Patients were grouped in good performance status (ECOG 0–1) and poor performance status (ECOG ≥2). The median progression free survival (PFS) was 7 months (95% CI 6.3–8.2) in patients with good PS and 3 months (95% CI 1.8–4.6) in patients with poor performance status (p<0.001). The median overall survival (OS) for patients with good performance status was 30 months (95% CI 16.6–42.3) and 4 months (95% CI 3.2–8.1) in patients with poor PS (figure 1). Adverse effects were recorded in a total of 83 (24%) patients, 18 (5%) patients had ECOG-PS 0, 50 (14%) patients had ECOG-PS 1, 18 (4%) patients had ECOG-PS 2 and 3 (1%) patients had ECOG-PS of 3. Most common adverse effects were pneumonitis (28%), diarrhea (8%) and hypothyroidism (8%).Abstract 221 Figure 1Progression free survival (PFS) and overall survival (OS) in patients with good performance status (ECOS PS 0–1) and poor performance status (ECOG ≥2) treated with immunotherapy in NSCLCConclusionsOur data suggests that while the patients with poor PS tolerated the immunotherapy. However, poor PS was associated with significantly lower PFS and OS. Further studies are required to evaluate the effect of PS on survival in frontline immunotherapy.AcknowledgementsWe thank Dr. Saqib Abbasi for helpful discussions.Trial RegistrationN/AEthics ApprovalThe study was approved by the Institution Review Board at KUMC, #CR00009003.ReferencesN/A

scholarly journals Phase II Clinical Trial of Gefitinib for the Treatment of Chemonaïve Patients with Advanced Non-small Cell Lung Cancer with Poor Performance Status

2014 ◽  
Vol 8 ◽  
pp. CMO.S15172 ◽  
Author(s):  
Nagla Abdel Karim ◽  
Salma Musaad ◽  
Ahmad Zarzour ◽  
Sadanand Patil ◽  
Abdul Rahman Jazieh
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Overall Survival ◽  
Performance Status ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Small Cell ◽  
Poor Performance Status ◽  
Small Cell Lung ◽  
Free Survival

Background Patients with advanced non-small cell lung cancer (NSCLC) have no curative treatment options; therefore, improving their quality of life (QOL) is an important goal. Gefitinib, an epidermal growth factor receptor (EGFR) inhibitor, is a safe oral agent that may be of benefit to a specific population of NSCLC. Patients and Methods A Phase II clinical trial included chemonaïve patients with advanced NSCLC and poor performance status (PS). Response rate, progression-free survival, overall survival, QOL using the Functional Assessment of Cancer Therapy – Lung (FACT-L) questionnaire, and Trial Outcome Index (TOI) were evaluated. Results Twelve out of 19 enrolled patients were evaluable. The median age for the evaluable patients was 68.8 years (59.7–74.6). Out of all the patients, 7 (58.3%) had adenocarcinoma and 5 (41.7%) had squamous cell carcinoma. The median duration of treatment was 62.5 days (26.5–115.0) in the evaluable patients. Grade 3/4 toxicities included fatigue, rash, diarrhea, and nausea. One patient had partial response, eight patients had stable disease (SD), and three patients progressed. The median overall survival for the evaluable population was 4.9 months (2.3–16). The median progression-free survival was 3.7 months (1.9–6.6). TOI was marginally associated with the overall survival, with a hazard ratio of 0.92 (95% confidence interval: 0.84, 1.0) ( P = 0.061). FACT-L score and the TOI were highly correlated ( r = 0.96, P < 0.0001). TOI scores were higher in African Americans compared to Caucasians and increased with age. Conclusion Our results suggest that gefitinib use in patients with NSCLC and poor PS may improve the QOL of older patients and African American patients.

Colorectal cancer in elderly patients: A single-center experience.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 576-576 ◽  
Author(s):  
G. Resch ◽  
M. Poetscher ◽  
W. Schauer ◽  
W. Hoebling ◽  
B. Mayrbaeurl ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Palliative Chemotherapy ◽  
Performance Status ◽  
Stage Iv ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Stage I ◽  
Stage Ii ◽  
Poor Performance Status ◽  
Free Survival

576 Background: In Austria more than 40% of cancers occur in adults over the age of 75 years. As the current population ages and more people live longer, the incidence of cancer in elderly patients (pts) is expected to rise. Several studies have shown that cancer treatment is beneficial for elderly pts in adjuvant and palliative setting. However, elderly pts with cancer have been underrepresented in clinical trials and there is little literature on this pts group. We now want to present our own experience in the treatment of elderly pts with colorectal cancer (CRC). Methods: Since July 2006 all pts with new diagnosed CRC were recorded in a tumor registry at the Klinikum Wels- Grieskirchen. Patients were followed for treatment decision, progression free survival and overall survival. In this retrospective analysis elderly pts >75 years diagnosed with CRC have been evaluated. Results: Overall, 165 pts >75 years (range 75-92) with a diagnosis of CRC stage I-IV were recorded from July 2006-July 2010 in our registry. Seventy-six (46.1%) and 89 (53.9%) out of these pts were men and women. Stage I has been diagnosed in 25 pts (15.2%), stage II in 57 pts (34.5%), stage III in 47 pts (28.5%) and stage IV in 36 pts (21.8%). 30.7 % (51 pts) had a tumor located in the rectum and 69.3% had colon cancer. 154 out of 165 pts underwent surgery (tumorectomy or colectomy). In one patient with stage II and in 11 pts with stage IV surgery was not possible because of poor performance status. Adjuvant chemotherapy was given in 8 pts with stage II and in 25/47 pts with stage III CRC. 11/36 pts were treated with palliative chemotherapy in stage IV CRC. 17 pts with stage I-III develop distant metastases and 11 out of these pts have been treated with palliative chemotherapy. Hemihepatectomy and lobectomy has been performed in 7 and 1 pts. Overall 13 pts (7.9%) were treated within a clinical trial for CRC. Chemotherapy regimens, progression free survival and overall survival data will be presented. Conclusions: Although elderly pts often have comorbidities and poor performance status, age alone should not determine treatment options and person's eligibility in clinical trials. A careful discussion of treatment risks and benefits, especially in elderly pts, needs to be considered in the therapy decision. No significant financial relationships to disclose.

Lenalidomide plus dexamethasone is more effective than dexamethasone alone in patients with relapsed or refractory multiple myeloma regardless of prior thalidomide exposure

Blood ◽  
2008 ◽  
Vol 112 (12) ◽  
pp. 4445-4451 ◽  
Author(s):  
Michael Wang ◽  
Meletios A. Dimopoulos ◽  
Christine Chen ◽  
M. Teresa Cibeira ◽  
Michel Attal ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Response Rate ◽  
Response Rate ◽  
Progression Free Survival ◽  
Efficacy And Safety ◽  
Time To Progression ◽  
Free Survival ◽  
Refractory Multiple Myeloma ◽  
Previously Treated ◽  
Survival Studies

AbstractThis analysis assessed the efficacy and safety of lenalidomide + dexamethasone in patients with relapsed or refractory multiple myeloma (MM) previously treated with thalidomide. Of 704 patients, 39% were thalidomide exposed. Thalidomide-exposed patients had more prior lines of therapy and longer duration of myeloma than thalidomide-naive patients. Lenalidomide + dexamethasone led to higher overall response rate (ORR), longer time to progression (TTP), and progression-free survival (PFS) versus placebo + dexamethasone despite prior thalidomide exposure. Among lenalidomide + dexamethasone-treated patients, ORR was higher in thalidomide-naive versus thalidomide-exposed patients (P = .04), with longer median TTP (P = .04) and PFS (P = .02). Likewise for dexamethasone alone-treated patients (P = .03 for ORR, P = .03 for TTP, P = .06 for PFS). Prior thalidomide did not affect survival in lenalidomide + dexamethasone-treated patients (36.1 vs 33.3 months, P > .05). Thalidomide-naive and thalidomide-exposed patients had similar toxicities. Lenalidomide + dexamethasone resulted in higher rates of venous thromboembolism, myelosuppression, and infections versus placebo + dexamethasone, independent of prior thalidomide exposure. Lenalido-mide + dexamethasone was superior to placebo + dexamethasone, independent of prior thalidomide exposure. Although prior thalidomide may have contributed to inferior TTP and PFS compared with thalidomide-naive patients, these parameters remained superior compared with placebo + dexamethasone; similar benefits compared with placebo + dexamethasone were not evident for thalidomide-exposed patients in terms of overall survival. Studies were registered at http://www.clinicaltrials.gov under NCT00056160 and NCT00424047.

scholarly journals Attenuated regimen of biweekly gemcitabine/nab-paclitaxel in patients aged 65 years or older with advanced pancreatic cancer

2020 ◽  
Vol 13 ◽  
pp. 175628482097491
Author(s):  
Hasan Rehman ◽  
Jeffrey Chi ◽  
Nausheen Hakim ◽  
Shreya Prasad Goyal ◽  
Coral Olazagasti ◽  
...  
Keyword(s):  
Pancreatic Cancer ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Advanced Pancreatic Cancer ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Poor Performance Status ◽  
Weekly Schedule ◽  
Dose Reductions

Background: Treatment with gemcitabine/nab-paclitaxel confers a survival benefit over gemcitabine monotherapy in patients with advanced pancreatic cancer (APC). However, such treatment can be associated with significant toxicities especially in older patients and carries practical disadvantages related to a weekly schedule along with financial cost. We retrospectively analyzed patients >65 years of age with APC who received a modified biweekly regimen of gemcitabine/nab-paclitaxel to evaluate efficacy and toxicity. Methods: Patients aged >65 years with chemo-naïve APC with Eastern Cooperative Oncology Group performance status ⩽2 were studied. Patients were treated with a modified regimen of gemcitabine 1000 mg/m2 and nab-paclitaxel 125 mg/m2 every 2 weeks on days 1 and 15 of a 28-day cycle. Patients were evaluated for progression-free survival (PFS) and overall survival (OS) with analyses performed using the Kaplan–Meier method. Adverse events were recorded on the day of chemotherapy. Cancer antigen 19.9 was measured in every cycle and restaging scans were performed every two cycles. Results: A total of 73 patients (median age: 73 years; range: 66–93) were treated with biweekly gemcitabine/nab-paclitaxel as first-line treatment. The median OS and PFS were 9.1 months and 4.8 months, respectively. Around 66% of patients received growth-factor support based on American Society of Clinical Oncology guidelines and no patient developed neutropenic fever. The incidences of grade ⩾3 toxicity for neutropenia, anemia, thrombocytopenia, and neurotoxicity were 2%, 7%, 3%, and 5%, respectively. Dose reductions of gemcitabine/nab-paclitaxel were required in 10% and 4% patients, respectively. Conclusion: In patients older than >65 years of age with APC, a modified regimen of biweekly gemcitabine/nab-paclitaxel was found to be effective when compared with the historical control from the MPACT study. This regimen allowed for fewer dose reductions, reduced healthcare costs from additional appointments, travel-related cost, as well as a favorable side-effect profile while maintaining efficacy. Though retrospective in nature, this study underlines the need for further investigation, particularly in elderly patients with poor performance status, such as those with pancreatic cancer, and in order to combine with a third agent, such as a targeted treatment or immunotherapy.

scholarly journals A Review of Docetaxel: Its Use in the Treatment of Gastric Cancer

2010 ◽  
Vol 2 ◽  
pp. CMT.S5191
Author(s):  
Alessandro Inno ◽  
Michele Basso ◽  
Alessandra Cassano ◽  
Carlo Barone
Keyword(s):  
Gastric Cancer ◽  
Phase Ii ◽  
Performance Status ◽  
Single Agent ◽  
Progression Free Survival ◽  
Poor Performance ◽  
Phase Iii ◽  
Poor Performance Status ◽  
Phase Ii Studies ◽  
Combination Regimens

Docetaxel, a member of the taxane family, promotes cell death by binding β-tubulin and has demonstrated activity against several human malignancies, both as a single agent and in combination therapy. It has been approved in Europe and the US as front-line treatment for advanced gastric cancer in combination with cisplatin and fluorouracil (DCF regimen). This approval was based on the results of a pivotal study (V325) which demonstrated that the addition of docetaxel to the reference regimen of cisplatin and fluorouracil improves overall survival and progression-free survival with a better quality of life despite increased toxicity (mainly haematological). Modifications of DCF regimen have been successfully investigated as a means of making the treatment more tolerable and suitable also for elderly patients or patients with poor performance status. Emerging data from several phase II studies suggest that other docetaxel-based combination regimens with anthracyclines or irinotecan have interesting activity with acceptable toxicity profiles, but the true efficacy of these regimens needs to be assessed in large randomized phase III studies. Thus, the best docetaxel-containing regimen has yet to be identified. Docetaxel also represents a good candidate for combination with novel molecular target agents. In light of the high response rates observed in phase II-III studies, a docetaxel-based chemotherapy regimen might also be considered a treatment option as perioperative or adjuvant therapy in potentially curable gastric cancer and further studies with or without biological agents are eagerly awaited in this setting.

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