scholarly journals Weekly chemotherapy as first line treatment in frail head and neck cancer patients in the immunotherapy era

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Andrea Botticelli ◽  
Giulia Pomati ◽  
Alessio Cirillo ◽  
Giulia Mammone ◽  
Fabio Ciurluini ◽  
...  
Keyword(s):  
Overall Survival ◽  
Head And Neck ◽  
Response Rate ◽  
Weekly Schedule ◽  
Line Treatment ◽  
First Line ◽  
Weekly Chemotherapy ◽  
Line Setting ◽  
Weekly Group ◽  
First Line Treatment

Abstract Objective First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, which have shown a significant improvement in overall survival (OS) gaining approval in a first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to 3-weeks treatment, was retrospectively evaluated in a frail patient population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach. Methods A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in a first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), overall survival (OS) and toxicities were analysed. Results Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients in weekly group (21) were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35% (36 patients) and 34% (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%). Conclusion The weekly schedule appears to be an active and safe strategy in frail patients with R/M HNSCC. Based on these data, a weekly schedule could be considered as a first line treatment in all frail patients excluded from pembrolizumab treatment and a study on the combination of weekly chemotherapy and immunotherapy should be performed.

scholarly journals Weekly Chemotherapy as First Line Treatment in Frail Head and Neck Cancer Patients in the Immunotherapy Era

2021 ◽  
Author(s):  
Andrea Botticelli ◽  
Giulia Pomati ◽  
Alessio Cirillo ◽  
Giulia Mammone ◽  
Fabio Ciurluini ◽  
...  
Keyword(s):  
Head And Neck ◽  
Response Rate ◽  
Low Grade ◽  
Weekly Schedule ◽  
First Line ◽  
Weekly Chemotherapy ◽  
Frail Patients ◽  
Significant Difference ◽  
Line Setting ◽  
Weekly Group

Abstract Objective: First-line therapy for metastatic squamous cell carcinoma of the head and neck (R/M HNSCC) has been revolutionized by the introduction of anti-checkpoint monoclonal antibodies, that have shown a significant improvement in overall survival (OS) gaining the approval in first line setting. Efficacy and safety of first-line weekly chemotherapy, compared to three-weeks treatment, was retrospectively evaluated in frail patients’ population with R/M HNSCC with the aim to evaluate its role as part of a personalized first-line approach.Methods: A total of 124 patients with locally incurable R/M HNSCC receiving weekly (21) or three-weekly (103) chemotherapy plus cetuximab in first line setting from December 2010 to September 2020 were retrospectively reviewed. Treatment outcomes in terms of objective response rate (ORR), progression-free survival (PFS), OS and toxicities were analyzed.Results: Patients in the three-week subgroup were ECOG PS 0 (39) and 1 (64) while patients (21) in weekly group were all PS 2. No significant differences were reported in terms of age, sex, smoking and previous alcohol abuse considering the two distinct subgroups. Moreover, no statistically significant difference was found in PFS and OS between the two treatment subgroups. The response rate was 35 % (36 patients) and 34 % (7 patients) in three-week and weekly treatment group, respectively. Seventy patients (68%) in the three-week group experienced chemotherapy-related toxicities, predominantly G3. In the weekly group a predominantly low-grade toxicity was found in a lower number of patients (52%).Conclusion: The weekly schedule appears an active and safe strategy in frail patients with R/M HNSCC. Based on our data, the weekly schedule could currently be considered in all frail patients and study of combination of weekly chemotherapy and immunotherapy should be performed.

Effect of the addition of bevacizumab to first-line FOLFOX on efficacy, including response rate, progression-free survival, and overall survival, in patients with metastatic colorectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 588-588
Author(s):  
M. Suenaga ◽  
N. Mizunuma ◽  
S. Matsusaka ◽  
E. Shinozaki ◽  
M. Ogura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Overall Survival ◽  
Metastatic Colorectal Cancer ◽  
Survival Benefit ◽  
Response Rate ◽  
Progression Free Survival ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
First Line Treatment

588 Background: Bevacizumab (BV) is a recombinant, humanized monoclonal antibody against vascular endothelial growth factor. Used in combination with chemotherapy, BV has been shown to improve survival in both first- and second-line treatment for metastatic colorectal cancer (mCRC). However, it was reported that addition of BV to FOLFOX conferred only little survival benefit (Saltz et al. JCO2008). The aim of this study was to assess the efficacy of addition of BV to FOLFOX in first-line treatment for patients with mCRC. Methods: Bevacizumab was approved for mCRC in July 2007 in Japan. This study was conducted at a single institution and comprised 217 consecutive patients receiving first-line treatment for mCRC between 2005 and 2009. The primary objective was to compare survival benefit in patients treated with FOLFOX4 (FF) between 2005 and 2007 with that in patients receiving FOLFOX4+BV 5 mg/kg (FF+BV) between 2007 and 2009. Results: Total number of patients in the FF and FF+BV groups was 132 and 85, respectively. Characteristics of patients were as follows (FF vs. FF+B): median age, 62 yrs (range 28-76 yrs) vs. 60 yrs (range16-74 yrs); ECOG PS0, 98.8% vs. 81.8%; and median follow-up time, 20.8 months vs. 24.4 months. Median progression-free survival (PFS) in the FF and FF+BV groups was 10 months (95% CI, 8.7-11.3) and 17 months (95% CI, 10.2-14.1), while median overall survival (OS) was 21 months (95% CI, 17.9-24.1) and not reached, respectively. Response rate was 46% (95% CI, 37- 54) in FF, and 62% (95% CI, 51-73) in FF+BV. Addition of BV to FOLFOX4 significantly improved PFS (p=0.002) and OS (p<0.001). Conclusions: The additive effect of BV for first-line FOLFOX was reconfirmed. These data indicate potential survival benefits from the addition of BV to FOLFOX in first-line treatment of mCRC. In addition, PFS may be a sensitive indicator of outcome prior to post-treatment. No significant financial relationships to disclose.

Fludarabine, Mitoxantrone and Dexamethasone for the First Line Treatment of Patients with Indolent Non-Hodgkin Lymphoma (NHL): GATLA First Interim Report (Grupo Argentino de Tratamiento de la Leucemia Aguda).

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 4680-4680
Author(s):  
Gustavo Milone ◽  
A. Rodriguez ◽  
Jorge Milone ◽  
R.F. Bezares ◽  
S. Rudoy ◽  
...  
Keyword(s):  
Overall Survival ◽  
Hodgkin Lymphoma ◽  
Response Rate ◽  
Response Rates ◽  
Low Grade ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
Non Hodgkin Lymphoma ◽  
First Line Treatment

Abstract Background: fludarabine (F) is licensed for the management of indolent non-Hodgkin lymphoma in countries such as Canada and Switzerland. Clinical evidence suggests that fludarabine monotherapy is as least as effective, than conventional therapies such as cyclophosphamide, vincristine, prednisone (CVP) for the first and second line treatment of B-cell low grade NHL achieving objective response rates. Better response rates can be achieved combining F with Mitoxantrone (N) and Dexamethasone (D) in indolent NHL patients (pts). The GATLA (Grupo Argentino de Tratamiento de la Leucemia Aguda) started a prospective multicenter national study to evaluate the use FND as a first line treatment for low grade NHL. Aims: to assess the response rate, safety, disease free survival (DFS) and overall survival (OS) of FND as first line treatment for indolent NHL during (2002–2006). Methods: Ninety-six patients in the period of January 2002 to April 2006 were recruited. Sixty-nine patients were valuable at the time of analysis. Median age 54 years old (range: 21–79). Gender: male 51% and female 49%. Inclusion criteria for low grade NHL-LG was: non-previous, age &gt; 18 years old with symptomatic disease, ECOG performance status 0–2 and written informed consent. Ann Arbor staging: 5,8%, 14,5%, 24,6% and 55%. FND treatment consisted of F 25 mg/m2 i.v. (days 1–3), N 10 mg/m m2 i.v. (day 1) and D 20 mg (days 1–5) each 28 days for 6 cycles. All patients received oral antibiotics for intestinal decontamination, antifungal prophylaxis and Trimethoprim-Sulfamethoxazole as P. carinii prophylaxis for one year. Results: on this low grade NHL cohort the overall response rate (ORR) was 93% (ORR) with 70% (48 pts) with complete response (CR) and 23% (16 pts) with partial response; progressive disease and non-response 7% (5 pts). The probability of event free survival (EFS) and overall survival (OS) at 24 months was 60% and 90% respectively. Two patients developed secondary malignancies after treatment and one died. Only one patient died in CR. Conclusions: in this population FND treatment demonstrate a high CR rate with low toxicity and high probability of EFS and OS as previous experience published in the literature.

scholarly journals Erlotinib and bevacizumab versus cisplatin, gemcitabine and bevacizumab in unselected nonsquamous nonsmall cell lung cancer

2015 ◽  
Vol 46 (1) ◽  
pp. 219-229 ◽  
Author(s):  
Michael Thomas ◽  
Jürgen Fischer ◽  
Stefan Andreas ◽  
Cornelius Kortsik ◽  
Christian Grah ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Cell Lung Cancer ◽  
Response Rate ◽  
Progression Free Survival ◽  
Nonsmall Cell Lung Cancer ◽  
Line Treatment ◽  
First Line ◽  
Free Survival ◽  
First Line Treatment

Erlotinib with bevacizumab showed promising activity in recurrent nonsquamous (NS) nonsmall cell lung cancer (NSCLC). The INNOVATIONS study was designed to assess in first-line treatment of unselected cisplatin-eligible patients this combination compared to cisplatin, gemcitabine and bevacizumab.Stage IIIB/IV patients with NS-NSCLC were randomised on erlotinib (150 mg daily) and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (EB) until progression, or cisplatin (80 mg·m−2 on day 1, every 3 weeks) and gemcitabine (1250 mg·m−2 on days 1 and 8, every 3 weeks) up to six cycles and bevacizumab (15 mg·kg−1 on day 1, every 3 weeks) (PGB) until progression.224 patients were randomised (EB n=111, PGB n=113). The response rate (12% versus 36%; p<0.0001), progression-free survival (median 3.5 versus 6.9 months; hazard ratio (HR) 1.85, 95% CI 1.39–2.45; p<0.0001) and overall survival (median 12.6 versus 17.8 months; HR 1.41, 95% CI 1.01–1.97; p=0.04) clearly favoured PGB. In patients with epidermal growth factor receptor mutations (n=32), response rate, progression-free survival and overall survival were not superior with EB.Platinum-based combination chemotherapy remains the standard of care in first-line treatment of unselected NS-NSCLC. Molecular targeted approaches strongly mandate appropriate testing and patient selection.

Gemcitabine (G) and cisplatin (C) as first-line treatment of metastatic breast cancer (MBC): Results of phase II trial.

2011 ◽  
Vol 29 (27_suppl) ◽  
pp. 273-273
Author(s):  
M. Karthaus ◽  
I. Poddubnaya ◽  
L. Churilova ◽  
R. Khasanov ◽  
T. Veremeychuk ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Response Rate ◽  
Phase Ii Trial ◽  
Metastatic Breast ◽  
Hematological Toxicity ◽  
Line Treatment ◽  
Toxicity Profile ◽  
First Line ◽  
First Line Treatment

273 Background: G has been studied in combination with a variety of agents known to be active in cancer. G has a mild toxicity profile. GC is active in various advanced tumors. Splitting of C dose (D 1 + d8) is better tolerated and can be a good alternative to once a cycle in pts with advanced breast cancer. This phase II trial evaluates G (1000 mg/m2) C (35 mg/ m2) d1+8 repeated every 21 d in the 1st-line treatment of metastatic breast cancer (MBC). The primary objective of the study was to determine the objective tumor response rate (ORR) of 1st-line GC in patients with metastatic breast cancer.The one-stage design tested the null hypothesis that the true response rate for this population should be equal to 50% for efficacy. Overall survival (OS), time to progression (TTP) and toxicity were evaluated. Methods: 70 female MBC pts with the median age of 49.8 ys (range 29.6-80.0) were enrolled. Tumor assessment was performed every other cycle by standard criteria including CT or MRI. 67 pts received a total of 310 cycles GC, out of these 54 pts were evaluable for efficacy. Results: Complete and partial responses were observed in 7/54 (13.0%) and 19/54 (35.2%) evaluable pts, respectively with an overall response of 48.2%. Disease stabilization was noticed in 19/54 (35.2%) pts. Progression was observed in 5/54 (9.3%) pts. TTP was 33.9 weeks (95% CI, 23.9-48.0). OS was 84.0 weeks (95% CI, 58.6-119.3). 1-year overall survival rate was 68.4% (95% CI, 53.6-79.3%). Hematological toxicity G4 was neutropenia in 14.9% (10/67), and no G4 thrombocytopenia. Hypotension G4 (1.5%) was the only severe non-hematological toxicity. Conclusions: GC in the first-line treatment of MBC, demonstrated a substantial overall response rate and had a good toxicity profile. GC is a suitable option for first-line MBC in selected pts.

Real-world experience with Lenvatinib in the management of Hepatocellular Carcinoma: A single-center Indian experience.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16596-e16596
Author(s):  
Amit Rauthan ◽  
S.P. Somashekhar ◽  
Poonam Patil ◽  
Shabber Zaveri
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Side Effects ◽  
Disease Control ◽  
Response Rate ◽  
Line Treatment ◽  
Single Center ◽  
First Line ◽  
Advanced Hcc ◽  
First Line Treatment

e16596 Background: Sorafenib has been the standard first line treatment for more than a decade in advanced Hepatocellular carcinoma (HCC) patients. Lenvatinib is a novel oral tyrosine kinase inhibitor which inhibits VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor alpha, RET and KIT, and has activity in multiple cancers. In the recent phase III REFLECT trial, Lenvatinib was non-inferior to Sorafenib in the first line management of advanced HCC. It showed better response rates, improved progression free survival (PFS) with similar overall survival (OS). There is no data of Lenvatinib in Indian patients. Methods: This is a single center, retrospective study, which included patients with metastatic or unresectable HCC who received treatment with Lenvatinib at our center. The endpoints were objective response rate (ORR), PFS and toxicity. Results: 31 patients received Lenvatinib from Dec 2017 to Oct 2019. Patients greater than 60kg received 12mg/day and those less than 60kg received 8mg/day. There were 5 females and 26 males. Median age was 60 years (29-78 years). All patients were BCLC stage C. Child Pugh score was A in 20 patients, B in 9 patients and C in 2 patients. AFP was elevated in 25 (80.6%) patients. 26 patients received Lenvatinib as initial therapy, 3 received it after Sorafenib progression, and 2 received after Sorafenib and Nivolumab progression. 6 patients (19.35%) achieved partial response (PR), 12 (38.7%) had stable disease and 13 (41.9%) had progressive disease by recist criteria. ORR was 19.35% and disease control rate was 58%. 2 patients underwent TACE after achieving PR. The median PFS was 7 months. The common adverse events were hypertension, weight loss, palmar plantar rashes, dysphonia and fatigue. Grade 3 AEs occurred in 8 patients (25.8%). 10 patients (32.2%) required dose reduction due to side effects. Conclusions: Lenvatinib has demonstrated a high response rate and disease control rate in our patients. Achieving a PFS of 7 months is an improvement over our previous Sorafenib experience. Further followup will demonstrate the overall survival. It is well tolerated and most side effects can be managed with patient education. The major advantage has been that in contrast to Sorafenib, only 32.2% patients required dose reduction due to side effects. These results are practice changing and Lenvatinib has become our first line regimen in advanced HCC. Lenvatinib would provide a good backbone to combine immunotherapy as first line treatment in future.

scholarly journals Cetuximab: a standard approach to the first-line treatment of recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck

2011 ◽  
pp. 247-256
Author(s):  
Jacques Bernier
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Metastatic Disease ◽  
Locally Advanced ◽  
Line Treatment ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
First Line Treatment

The burden of squamous cell carcinoma of the head and neck (SCCHN) on healthcare systems is expected to rise in line with projected increases in population sizes in general, and the relative proportion of elderly individuals in particular, underlining the need for effective, well tolerated treatment strategies. The epidermal growth factor receptor (EGFR)-targeted IgG1 monoclonal antibody, cetuximab, is the only EGFR-targeted agent currently approved for use in the treatment of SCCHN. Adding cetuximab to standard first-line platinum-based chemotherapy in the treatment of recurrent and/or metastatic SCCHN significantly improved overall survival (hazard ratio [HR] 0.80; P = 0.04), progression-free survival (HR 0.54; P\0.001) and response rates (odds ratio 2.33; P\0.001), compared to platinum-based chemotherapy alone. This was the first time in 30 years that a significant increase in overall survival had been achieved over platinum- based therapy alone and established cetuximab plus platinum-based chemotherapy as the new standard first-line treatment approach for recurrent and/or metastatic disease. In locally advanced SCCHN, cetuximab plus radiotherapy significantly improved locoregional control (HR 0.68, P = 0.005) and overall survival (HR 0.74; P = 0.03) compared to radiotherapy alone. In both recurrent and/or metastatic disease and locally advanced disease, adding cetuximab to standard therapy was generally well tolerated and did not affect patients’ quality of life. The clinical benefits seen with the addition of cetuximab to standard chemotherapy or radiotherapy make it one of the most significant advances made in SCCHN treatment in recent years.

scholarly journals Cetuximab: a standard approach to the first-line treatment of recurrent and/or metastatic and locally advanced squamous cell carcinoma of the head and neck

2011 ◽  
Vol 3 (4) ◽  
pp. 247
Author(s):  
Jacques Bernier
Keyword(s):  
Overall Survival ◽  
Squamous Cell Carcinoma ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Metastatic Disease ◽  
Locally Advanced ◽  
Line Treatment ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
First Line Treatment

The burden of squamous cell carcinoma of the head and neck (SCCHN) on healthcare systems is expected to rise in line with projected increases in population sizes in general, and the relative proportion of elderly individuals in particular, underlining the need for effective, well tolerated treatment strategies. The epidermal growth factor receptor (EGFR)-targeted IgG1 monoclonal antibody, cetuximab, is the only EGFR-targeted agent currently approved for use in the treatment of SCCHN. Adding cetuximab to standard first-line platinum-based chemotherapy in the treatment of recurrent and/or metastatic SCCHN significantly improved overall survival (hazard ratio [HR] 0.80; P = 0.04), progression-free survival (HR 0.54; P\0.001) and response rates (odds ratio 2.33; P\0.001), compared to platinum-based chemotherapy alone. This was the first time in 30 years that a significant increase in overall survival had been achieved over platinum- based therapy alone and established cetuximab plus platinum-based chemotherapy as the new standard first-line treatment approach for recurrent and/or metastatic disease. In locally advanced SCCHN, cetuximab plus radiotherapy significantly improved locoregional control (HR 0.68, P = 0.005) and overall survival (HR 0.74; P = 0.03) compared to radiotherapy alone. In both recurrent and/or metastatic disease and locally advanced disease, adding cetuximab to standard therapy was generally well tolerated and did not affect patients’ quality of life. The clinical benefits seen with the addition of cetuximab to standard chemotherapy or radiotherapy make it one of the most significant advances made in SCCHN treatment in recent years.

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