Subanalysis of the StiL NHL 1–2003 Study: Achievement of Complete Response with Bendamustine-Rituximab (B-R) and CHOP-R in the First-Line Treatment of Indolent and Mantle Cell Lymphomas Results in Superior Survival Compared to Partial Response.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2724-2724 ◽  
Author(s):  
Mathias J. Rummel ◽  
Norbert Niederle ◽  
Georg Maschmeyer ◽  
G.-Andre Banat ◽  
Ulrich von Grünhagen ◽  
...  
Keyword(s):  
Complete Response ◽  
Line Treatment ◽  
First Line ◽  
Female Patients ◽  
Significant Difference ◽  
Mantle Cell ◽  
Male Patients ◽  
The Impact ◽  
First Line Treatment

Abstract Abstract 2724 Background: The NHL 1 study, a prospective, multicenter, randomized, phase 3 study which compared B-R and CHOP-R as first-line treatment in indolent lymphomas and mantle cell lymphoma (MCL), demonstrated a significant benefit in progression-free survival (PFS) as well as improved tolerability for B-R compared with CHOP-R. Here we present an analysis of the impact of response quality on outcome. Methods: 514 patients (pts) with indolent or MCL were randomized to receive B-R or CHOP-R for a maximum of 6 cycles. Results: The overall response rate in the 514 pts (261 B-R; 253 CHOP-R) was 92.7% and 91.3% in the B-R and CHOP-R arms, respectively (as presented at the last ASCO meeting, J Clin Oncol 30, 2012 (suppl; abstr 3). A complete response (CR) was observed in 39.8% in the B-R arm and in 30% in the CHOP-R arm (p=0.021). The achievement of CR was associated with a significantly prolonged PFS and overall survival (OS) (Table 1). Analysis by treatment arm revealed a trend for superior PFS and a significantly improved OS for patients achieving CR following treatment with B-R. In the CHOP-R arm, patients in CR had a significantly superior PFS compared to those in PR with a trend to superior OS. Regardless of the quality of response, PFS was superior with B-R versus CHOP-R: For patients in CR, the median PFS was not reached with B-R, whereas for CHOP-R it was 53.7 months (p=0.0204). In patients achieving PR, treatment with B-R resulted in a median PFS of 57.2 months, and this was 30.9 months with CHOP-R (p=0.0002). We noted a statistically significant difference in CR rates between male (n=272, median age 63 years) and female (n=242, median age 64 years) patients. The CR rate was 28.6% in male patients and 42.1% in female patients (p=0.0016). Female patients had a longer median PFS (51.4 months) compared to male patients (38.6 months), however, this difference was not statistically significant (p=0.0866). Conclusions: Patients in CR following first-line treatment in our study had a significantly longer PFS and OS compared to those achieving a PR. Therefore, our results strongly suggest an association between quality of response and outcome. Disclosures: No relevant conflicts of interest to declare.

Management of skin toxicity and cetuximab-based regimen compliance in first-line chemotherapy of metastatic colorectal cancer (mCRC) patients (pts): Results of observer study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e14557-e14557
Author(s):  
Carmine Pinto ◽  
Francesca Di Fabio ◽  
Gerardo Rosati ◽  
Ivan Lolli ◽  
Enzo Ruggeri ◽  
...  
Keyword(s):  
Liver Metastasis ◽  
Skin Toxicity ◽  
Efficacy Rate ◽  
Vitamin K1 ◽  
Line Treatment ◽  
First Line ◽  
Observer Study ◽  
Significant Difference ◽  
The Impact ◽  
First Line Treatment

e14557 Background: Cetuximab significantly improves efficacy when added to chemotherapy in mCRC pts. The ObservEr Study evaluated quality of life (QoL), skin toxicity management and treatment compliance of cetuximab-based regimens in first-line treatment of mCRC pts. Methods: ObservEr is a non-interventional, multicenter, prospective study. Primary endpoint is change in QoL during first-line treatment, with focus on the impact of dermatological toxicity. QoL (Dermatology Life Quality Index/DLQI and EORTC QLQ C30) is assessed at baseline and weekly for the first 8 weeks of treatment, then at every evaluation visit until PD or withdrawal. Secondary endpoints are efficacy, rate of liver metastasis resections, incidence of serious adverse events. Results: Between Apr 2011 and Nov 2012, 29 Italian centers enrolled 233 pts, with 226 evaluable pts. Pt characteristics: 152(67.3%) males, 74(32.7%) females; median age 65 (39-81) years; PS ECOG 0-1 95.5%; potentially resectable liver metastasis 59(27.1%); irinotecan regimens 129(57.1%), oxaliplatin regimens 60(26.5%), other regimens 37(16.4%). Median interval between request and result of KRAS test was 10 (6-15) days. Prophylactic skin treatment with vitamin K1 cream was used in 159(70.4%) pts, reactive treatment included vitamin K1 in 59(26.1%). Grade (gr) 1-2 skin toxicity was observed in 128(56.6%) pts, gr 3 in 28(12.4%); no gr 4 was detected. No significant difference in gr 3 skin toxicity was observed between males vs females (13.8 vs 9.5%; p=0.351), age <60 vs ≥60 years (18.1 vs 9.7%; p=0.077), irinotecan vs oxaliplatin regimens (12.4 vs 18.3%; p=0.278), prophylactic vs reactive treatment (15.1 vs 6.8%; p=0.339). Dose reduction, temporary and permanent discontinuation of cetuximab due to skin toxicity was required in 9(4.0%), 32(14.2%) and 7(3.1%) pts respectively; cetuximab compliance ≥70% of dose was reached in 208(92.0%) pts. Conclusions: These results suggest that appropriate skin toxicity management and prophylactic or reactive treatment with Vitamin K1 cream can improve the gr 3 skin toxicity control and the cetuximab compliance. QoL results will be shown at the 2013 ASCO Meeting. Clinical trial information: ID239.

Prognostic importance of primary tumor resection and synchronous metastasis on overall survival in metastatic colorectal cancer: Data from the FIRE-3 (AIO KRK-0306) study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4070-4070
Author(s):  
Jobst C. von Einem ◽  
Sebastian Stintzing ◽  
Ludwig Fischer von Weikersthal ◽  
Thomas Decker ◽  
Alexander Kiani ◽  
...  
Keyword(s):  
Overall Survival ◽  
Primary Tumor ◽  
Tumor Resection ◽  
Primary Tumor Resection ◽  
P Value ◽  
Line Treatment ◽  
First Line ◽  
Significant Difference ◽  
The Impact ◽  
First Line Treatment

4070 Background: The FIRE-3 study (AIO KRK-0306) was designed as a randomized multicenter trial to compare the efficacy of FOLFIRI plus cetuximab (cet) to FOLFIRI plus bevacizumab (bev) as first-line treatment in KRAS WT mCRC patients. FOLFIRI plus cet as first-line treatment of KRAS WT mCRC patients resulted in comparable overall response rates (ORR) and progression free survival (PFS) when compared to FOLFIRI plus bev. Overall survival (OS) was significantly longer in the FOLFIRI plus cet arm. Methods: In the present analysis of the FIRE-3 trial we explored the impact of primary tumor resection on outcome in relation to anti-EGFR vs. anti-VEGF treatment. Furthermore, we investigated the prognostic value of synchronous versus metachronous metastases. Results: In patients with synchronous disease no significant difference in OS was detected when comparing resected (n=339) vs. non-resected (n=97) patients (p-value: 0.29, HR: 1.17, 95%-CI: 0.88 – 1.55). In the cetuximab arm, resection (n=167) showed no significant benefit in OS when compared to non-resection (n=52) (p-value: 0.51, HR: 1.15, 95%-CI: 0.77 – 1.71). Treated with bevacizumab, similar results were present, when comparing resection (n=172) vs. non-resection (n=45); (p-value: 0.29, HR: 1.25, 95%-CI: 0.83 – 1.9). A strong trend was seen when comparing OS in treatment arms cet. (n=219) vs. bev. (n=217)) for patients with synchronous disease; (p-value: 0.05, HR: 1,26, 95%-CI: 1.0 - 1.59). 436/592 pts suffered from synchronous, 153/592 from metachronous disease (in 3/592 pts the information was not given). Median OS in pts with synchronous disease was 24.5 months and 29.5 in pts with metachronous disease (p-value: 0.02, HR: 0.76, 95%-CI: 0.6 - 0.96). In pts treated in the cetuximab arm metachronous disease (n=77) was associated with a trend towards longer OS when compared to synchronous disease (n= 219) (p-value: 0.13, HR: 0.76, 95%-CI: 0.54 – 1.1). The same effect was present in the bevacizumab arm (p-value: 0.05, HR: 0.73, 95%-CI 0.53 – 1.0) when comparing pts with synchronous disease (n=217) vs. pts. with metachronous disease (n=76). Conclusions: In the FIRE-3 study, metachronous disease was associated with superior OS compared to synchronous disease. This finding was accentuated in the bevacizumab arm. The role of resection of the primary tumor had no impact on survival. Clinical trial information: NCT00433927 .

Updated overall survival results of WJTOG 3405, a randomized phase III trial comparing gefitinib (G) with cisplatin plus docetaxel (CD) as the first-line treatment for patients with non-small cell lung cancer harboring mutations of the epidermal growth factor receptor (EGFR).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 7521-7521 ◽  
Author(s):  
Tetsuya Mitsudomi ◽  
Satoshi Morita ◽  
Yasushi Yatabe ◽  
Shunichi Negoro ◽  
Isamu Okamoto ◽  
...  
Keyword(s):  
Overall Survival ◽  
Phase Iii ◽  
Line Treatment ◽  
First Line ◽  
Significant Difference ◽  
The Impact ◽  
Egfr Tki ◽  
First Line Treatment ◽  
Platinum Doublet

7521 Background: WJTOG3405 met its primary endpoint of progression free survival (PFS) (9.2 months (mo.) for G vs. 6.3 mo. for CD, hazard ratio (HR) 0.489, 95% confidence interval (CI): 0.336-0.710). (Mitsudomi et al., Lancet Oncol., 2010). However, the impact on overall survival (OS) was not clear then because of relatively short follow-up period. Methods: Overall survival (OS) was re-evaluated using updated data (data cutoff, 31 July, 2011, median follow-up, 34 months) for 172 patients. Results: Eighty-two events had occurred (48%). Median survival time (MST) for G arm was 36 mo. (95% CI: 26.3 -) which was not significantly different from 39 mo. (95% CI: 31.2 -) for CD arm (HR 1.185, 95% CI 0.767-1.829). Multivariate analysis using Cox proportional hazards model revealed that none of covariates (treatment arm, smoking status, sex, age, postoperative recurrence or IIIB/IV, and mutation type) significantly affected OS. In the G arm, MST of patients with exon 19 deletion (36 mo.) was comparable to that of patients with L858R (35 mo.). In the CD arm, 78 patients (91%) received EGFR-TKI as the 2nd or later line treatment, whereas in the G arm, 52 patients (61%) received platinum doublet. Accordingly, 130 patients received both platinum doublet and EGFR-tyrosine kinase inhibitor (TKI) and 34 patients received EGFR-TKI without platinum doublet in their whole courses of therapy. MST for the former and the latter group were 36 months (95% CI: 31.2-45.7) and 45 months (95% CI: 25.6-), without significant difference. Conclusions: This update OS analysis revealed that G for advanced NSCLC with EGFR mutation offers distinct survival benefit of 3 years. There was no difference in OS whether the first-line treatment was G or CD, in accordance with the precedent studies. The reason why PFS difference was not translated into OS difference is probably due to high cross over rate to EGFR-TKI. However, it was noteworthy that 40% of patients in the G arm could be managed without platinum doublet and yet had similar outcome.

Real life data from Turkey regarding the impact of first-line sunitinib and pazopanib in metastatic renal cell cancer.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e16075-e16075 ◽  
Author(s):  
Ulas Isik ◽  
Osman Kostek ◽  
Gokcen Demiray ◽  
Ahmet Dirican ◽  
Melih Simsek ◽  
...  
Keyword(s):  
Overall Survival ◽  
Renal Cell ◽  
The Other ◽  
Line Treatment ◽  
First Line ◽  
Treatment Approaches ◽  
Common Cancer ◽  
Significant Difference ◽  
The Impact ◽  
First Line Treatment

e16075 Background: Although the distribution in the world varies widely, renal cell carcinoma (RCC) is the ninth most common cancer, especially in males. It’s the seventh most common cancer in Turkey. In this study, the progression-free survival (PFS) and overall survival (OS) of patients with metastatic RCC (mRCC) who were treated at 13 centers in our country were evaluated and the efficacy of first-line treatment approaches was compared. Methods: Data of mRCC patients admitted to 13 outpatient clinics in Turkey between 2008 and 2018 were reviewed retrospectively. Demographic characteristics, pre-treatment clinical evaluations, information about treatment approaches and survival outcomes of the patients were collected. All medical records were collected by a detailed review of the patients’ charts. The median and percentage values were frequently signified for defining of central trends. Kaplan-Meier method was applied for OS analyzes and log-rank test with Cox-regression models were applied for the evaluation of prognostic factors. Results: Data from files of 262 patients were reviewed. Twelve of these patients were excluded from the study because they could not receive treatment due to comorbidities and other reasons at metastatic stage of the disease. Of the patients, 100 (40%) were female and 150 (60%) were male. Median age was 60 (range 21-83). For the entire group, the median PFS (mPFS) was 27.6 months and the median overall survival (mOS) was 46.1 months. In terms of first-line treatment of metastatic disease, 41.3% of the patients received sunitinib, 48.8% of the patients received pazopanib, 15.8% of the patients received other treatments. PFS of the patients receiving sunitinib, pazopanib and the other treatments were 26.3 months, 34.2 months and 14.2 months, respectively. There was no statistically significant difference between PFS of the patients receiving sunitinib and pazopanib (p = 0.05). mOS was 54 months in sunitinib arm, 54.9 months in pazopanib arm and 23.3 months in the other treatment arm. There was no statistically significant difference between two treatment agents in terms of mOS (p = 0.43). Conclusions: Pazopanib was more commonly prescribed in Turkey. There were no statistically significant differences between mPFS and mOS of the patients who received sunitinib and pazopanib for the first-line treatment of mRCC. With increased use of immunotherapeutic agents for the first-line treatment of mRCC in our country, improvement in mOS could be expected.

scholarly journals Comprehensive analysis of maintenance therapy after first-line treatment with pemetrexed and platinum-containing double drug regimen combined by bevacizumab in EGFR wild type advanced non-squamous NSCLC.

2019 ◽  
Vol 5 (suppl) ◽  
pp. 133-133
Author(s):  
XiangHua Zhang ◽  
LiXia Ma ◽  
Ying Cheng ◽  
HongXia Cui
Keyword(s):  
Quality Of Life ◽  
Maintenance Therapy ◽  
Line Treatment ◽  
Wild Type ◽  
First Line ◽  
Curative Effect ◽  
Significant Difference ◽  
Eortc Qlq ◽  
First Line Treatment

133 Background: Pemetrexed combined with platinum was the standard treatment for first-line EGFR wild type non-squamous NSCLC , but further research is needed to confirm the safety of pemetrexed and bevacizumab treatment in maintenance therapy after first-line treatment in advenced non-squamous NSCLC. Methods: Total 60 patients with newly diagnosed advanced non-squamous NSCLC admitted to the hospital from June 2015 to June 2017, which were ARMS confirmed the EGFR wild type. In the observation group, bevacizumab +pemetrexed+ platinum was maintained with bevacizumab (BAP-B group). Control group: bevacizumab + pemetrexed + platinum was maintained with pemetrexed (BAP-A group). 60 patients completed 4- 6 cycles of chemotherapy and maintenance therapy for more than 4 cycles. The curative effect was evaluated According to Recis 1.1.The toxic reaction was evaluated WHO chemotherapeutic drug toxicity. The quality of life of patients were evaluated by EORTC QLQ-LC43. All the data were processed by SPSS19.0. P < 0.05 was statistically significant. Results: 33 cases in BAP-B and 27 cases in BAP-A . In this study, BAP-B & BAP-A : ORR 61.0% & 50.0% (P > 0.05);DCR 73.5 & 64.8 % ( P>0.05), median PFS 9.6 m & 7.2 m (P < 0.05), OS:18.2 m & 12.6 m (P < 0.05). Adverse incidence: BAP-B & BAP-A: leukopenia rate 43.0% & 41.2% hemoglobin reduction 40.0% & 38.5%; The reaction rate of digestive tract was 35.3% & 34.5%. There was no significant difference between the two groups. The incidence of hypertension in BAP-B (18.8%) was higher than that in BAP-A (0%) (P < 0.05). The incidence of proteuria in BAP-B (8.8%) was higher than that in BAP-A (2.0%) (P < 0.05), BAP-A and BAP-B (P < 0.05). The quality of life score of EORTC QLQ-C43 was (73.17 ±2.75) & (59.68 ±2.52), which was higher than that before treatment (52.75 ±2.02) & (53.01 ±1.98), and the score of BAP-A was higher than that of BAP-B(P < 0.05). Conclusions: The first line treatment of advanced EGFR wild type non-squamous NSCLC needs comprehensive consideration of curative effect, survival time, safety, quality of life and economic problems in order to choose the most suitable treatment.

Impact of empirically eliminating 5-fluorouracil (5-FU) bolus and leucovorin (LV) in patients with metastatic colorectal cancer (mCRC) receiving first-line treatment with mFOLFOX6.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 4022-4022 ◽  
Author(s):  
Alexa Basilio ◽  
Anand Shah ◽  
Katelyn Sommerer ◽  
Sarah Chehab ◽  
Salvatore Michael Bottiglieri ◽  
...  
Keyword(s):  
Growth Factor ◽  
Palliative Therapy ◽  
Retrospective Chart Review ◽  
Cancer Center ◽  
Line Treatment ◽  
First Line ◽  
Significant Difference ◽  
Grade 3 ◽  
The Impact ◽  
First Line Treatment

4022 Background: Systemic chemotherapy with a 5-FU-based regimen, such as mFOLFOX6, is the preferred first line treatment option for mCRC. Due to hematologic toxicities associated with the 5-FU bolus component, providers may choose to eliminate it empirically in patients receiving palliative therapy. This study aimed to assess the impact of empirically eliminating the 5-FU bolus and LV from first line treatment with mFOLFOX6 in mCRC. Methods: This was a retrospective chart review of patients ≥ 18 years old with mCRC receiving palliative first line mFOLFOX6 chemotherapy with (bolus) or without (non-bolus) the 5-FU bolus and LV components from January 1, 2015 through August 31, 2019 at Moffitt Cancer Center. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), disease control rate (DCR) defined as partial response and stable disease at first scan, utilization of growth factor support and safety. Results: Data analysis cutoff was December 31, 2019, with 61 patients included in the bolus arm and 72 in the non-bolus arm. Median follow-up time was 21.8 months. No difference was found in median PFS (8.12 vs. 6.64 months, p=0.787) or OS (29.36 vs. 21.6 months, p=0.395) between the bolus and non-bolus arms, respectively. Observed DCR at first scan was similar between both arms (47.3% vs. 52.7%, p=0.44). Utilization of growth factor support was significantly higher in the bolus arm (73.7% vs. 26.3%, p=0.012). Fewer grade ≥ 3 treatment-related hematologic adverse events (AE) were seen in the non-bolus arm (37.7% vs. 22.2%, p=0.058) (table). Conclusions: This is the only study to date that analyzed the impact of empirically eliminating 5-FU bolus and LV from first line palliative therapy with mFOLFOX6 in mCRC. Results showed no significant difference in median PFS or OS. Despite reduced growth factor utilization, the non-bolus arm demonstrated a favorable safety profile with less treatment-related hematologic grade ≥ 3 AE. The results of this study warrant consideration of empirically eliminating 5-FU bolus and LV from the mFOLFOX6 regimen to avoid additive toxicities without negatively impacting efficacy. [Table: see text]

scholarly journals Postinfectious Olfactory Dysfunction: Oral Steroids and Olfactory Training versus Olfactory Training Alone: Is There any Benefit from Steroids?

ORL ◽  
2021 ◽  
pp. 1-8
Author(s):  
Sotiria Genetzaki ◽  
Evangelia Tsakiropoulou ◽  
Vasilios Nikolaidis ◽  
Konstantinos Markou ◽  
Iordanis Konstantinidis
Keyword(s):  
Olfactory Dysfunction ◽  
Olfactory Function ◽  
Line Treatment ◽  
First Line ◽  
Olfactory Testing ◽  
Significant Difference ◽  
Oral Steroids ◽  
Group A ◽  
Olfactory Training ◽  
First Line Treatment

<b><i>Introduction:</i></b> There are limited treatment options for postinfectious olfactory dysfunction (PIOD). Olfactory training has recently been used in clinical practice, but no medical treatment is widely accepted. Although there is weak evidence for their value, some physicians use oral corticosteroids as first-line treatment. The aim of this study was to compare combined oral methylprednisolone and olfactory training with olfactory training alone in the management of PIOD. <b><i>Methods:</i></b> This prospective cohort study included 131 patients with PIOD over a 2-year period before the COVID-19 pandemic. Seventy-eight patients who were treated with oral methylprednisolone and olfactory training (group A) were compared with 53 patients who were treated with olfactory training only (group B). Olfactory function was evaluated with “Sniffin’ Sticks” at baseline and 2, 8, and 16 weeks after initial assessment. Patients who improved after steroid treatment underwent magnetic resonance imaging of the paranasal sinuses, skin prick tests, lung spirometry, and sputum eosinophil assessment. <b><i>Results:</i></b> Oral steroids improved 19.23% of patients (<i>n</i> = 15) of group A. History, clinical evaluation, imaging, and laboratory tests identified an inflammatory background in half of them (<i>n</i> = 8). The remaining 7 had no findings of nasal inflammation, and all had a short history of olfactory dysfunction. Both groups significantly improved in olfactory testing results at the end of the olfactory training scheme without significant difference between them. <b><i>Conclusions:</i></b> The percentage of improved patients after oral methylprednisolone was relatively low to suggest it as first-line treatment. Half of the improved patients had an underlying upper airway inflammatory condition not related to the infection that caused the acute loss of olfactory function.

scholarly journals Review of Treatment Options for the Management of Advanced Stage Hodgkin Lymphoma

Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3745
Author(s):  
Hélène Vellemans ◽  
Marc P. E. André
Keyword(s):  
Hodgkin Lymphoma ◽  
New Drugs ◽  
Western World ◽  
Tumor Control ◽  
Advanced Stage ◽  
Line Treatment ◽  
First Line ◽  
Remission Rates ◽  
The Impact ◽  
First Line Treatment

Hodgkin lymphoma (HL) is a lymphoid-type hematologic disease that is derived from B cells. The incidence of this lymphoid malignancy is around 2–3/100,000/year in the western world. Long-term remission rates are linked to a risk-adapted approach, which allows remission rates higher than 80%. The first-line treatment for advanced stage classical HL (cHL) widely used today is doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) or escalated bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPPesc) chemotherapy. Randomized studies comparing these two regimens and a recently performed meta-analysis have demonstrated consistently better disease control with BEACOPPesc. However, this treatment is not the standard of care, as there is an excess of acute hematological toxicities and therapy-related myeloid neoplasms. Moreover, there is a recurrent controversy concerning the impact on overall survival with this regimen. More recently, new drugs such as brentuximab vedotin and checkpoint inhibitors have become available and have been evaluated in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for the first-line treatment of patients with advanced cHL with the objective of tumor control improvement. There are still major debates with respect to first-line treatment of advanced cHL. The use of positron emission tomography-adapted strategies has allowed a reduction in the toxicity of chemotherapy regimens. Incorporation of new drugs into the treatment algorithms requires confirmation.

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