Randomized Comparison of ACVBP and m-BACOD in the Treatment of Patients With Low-Risk Aggressive Lymphoma: The LNH87-1 Study

2000 ◽  
Vol 18 (6) ◽  
pp. 1309-1315 ◽  
Author(s):  
Hervé Tilly ◽  
Nicolas Mounier ◽  
Pierre Lederlin ◽  
Josette Brière ◽  
Brigitte Dupriez ◽  
...  
Keyword(s):  
Group Performance ◽  
Remission Rate ◽  
Performance Status ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Tumor Burden ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Standard Regimen

PURPOSE: To compare a short intensified regimen followed by sequential consolidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, cyclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressive lymphoma. PATIENTS AND METHODS: A total of 752 patients with intermediate- or high-grade lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, ≥ two extranodal sites of disease, tumor burden ≥ 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt’s or lymphoblastic subtypes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. RESULTS: The complete remission rate was identical (86%) in the two groups. With a median follow-up duration of 7 years, the 5-year failure-free survival (FFS) rate was 65% in the ACVBP group and 61% in the m-BACOD group (P = .16). The 5-year overall survival rate was 75% in the ACVBP group and 73% in the m-BACOD group (P = .47). ACVBP was responsible for more severe and life-threatening infections (P < .01), but m-BACOD caused more pulmonary toxicity (P < .001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP was associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. CONCLUSION: In this population of patients with low-risk aggressive lymphoma, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regimen in patients with advanced disease is suggested by this analysis but remains to be assessed in prospective studies specifically designed for this purpose.

Treatment Outcome of Aggressive Lymphoma with CyclOBEAP (CHOP-Like + Etoposide and Bleomycin): Results of Multicenter Trial.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3303-3303
Author(s):  
Masataka Okamoto ◽  
Nozomi Niitsu ◽  
Sadao Aoki ◽  
Yasunobu Kuraishi ◽  
Hirokazu Okumura ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Liver Damage ◽  
Performance Status ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Dose Intensity ◽  
Aggressive Lymphoma ◽  
Who Grade ◽  
Bulky Disease ◽  
Total Period

Abstract Introduction: To improve treatment outcome in aggressive lymphoma, a CHOP-like regimen with added etoposide and bleomycin was studied. Patients and Methods: Between April 1997 and March 2003, 126 consecutive patients (pts) with aggressive lymphoma of low-intermediate to high risk disease according to the age adjusted International Prognostic Index (IPI), age<61 years, and performance status(ECOG)<3 were treated with CyclOBEAP. MCL and ATL/L were excluded from this study. CyclOBEAP was a weekly protocol for a total period of 12 weeks. It consisted of doxorubicin 50mg/m2 given every 2 weeks in combination with either cyclophosphamide 1,000mg/m2 (weeks 1, 5, 9) or etoposide 70mg/m2 qd x4 (weeks 3, 7, 11). During the alternative weeks non-myelosuppressive vincristine 1.4mg/m2 (max. 2.0mg/body) was given either with bleomycin 10mg/m2 (weeks 2, 6, 10) or alone (weeks 4,8,12). Prednisolone 40mg/m2 was administered daily for 14 days during weeks 1–2, 5–6, and 9–10. Protocol dose intensity relative to that of CHOP was 1.5 for DXR, VCR and 1.0 for CPA. G-CSF was prophylactically used. Pts who had had a bulky disease at presentation received 40Gy of local irradiation after chemotherapy. Results: One hundred twenty-six pts were enrolled and 5 were excluded from analysis; 3 due to change of diagnosis ( ATL/L, Hodgkin lymphoma, germ cell tumor), 1 due to PS4 and the other due to drop out. In 121 eligible pts (DLBCL 94, PTCL 11, ALCL 7, nasal NK/T 4, others 5), 7 pts did not complete the full course of the treatment because of pneumonia (3), liver damage (1), intrathoracic hemorrhage (1), and PD response at 8th week (2). Relative given dose intensity was 0.94 for DXR, 0.95 for CPA, 0.86 for VCR, 0.94 for VP16, and 0.96 for BLM. All pts were evaluated. CR (including cCR) was obtained in 106 (88%), PR in 11 and NC/PD in 4. No treatment related death was observed. With a median follow-up of 56 months, 5yr overall survival (OS) rate is 72% and progression-free survival (PFS) rate is 62%. The 5yr OS and PFS within the subgroups defined by IPI and in pts with DLBCL and PTCL are not significantly different (data shown in the table). WHO grade 4 neutropenia was observed in 91 pts and thrombocytepenia in 13 pts. 66 pts required 2 or more units of red cell transfusions (2 – 66 units). Liver damage of grade 3 to 4 was seen in 3 pts. Conclusions: Addition of etoposide and bleomycin to CHOP drugs may enhance the effect of CHOP for aggressive lymphoma, encouraging comparative study between the two treatments. n CR (%) 5yr OS 5yr PFS *OS:Log-Rank 0.578; Wilcoxson 0.616 *PFS:Log-Rank 0.552; Wilcoxson 0.573 #OS:Log-Rank 0.049; Wilcoxson 0.059 #PFS:Log-Rank 0.122; Wilcoxson 0.146 All 121 106 ( 88) 72 % 62 % IPI: L-I* 41 37 ( 90) 69 65 IPI: H-I* 62 56 ( 90) 71 55 IPI: H* 18 13 ( 72) 82 43 DLBCL# 94 82 ( 87) 70 58 PTCL# 11 11 (100) 100 82

PILLAR-2: A randomized, double-blind, placebo-controlled, phase III study of adjuvant everolimus in poor-risk diffuse large B-cell lymphoma (DLBCL).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS8118-TPS8118 ◽  
Author(s):  
Tongyu Lin ◽  
Jun Zhu ◽  
Kamal Bouabdallah ◽  
Michinori Ogura ◽  
Masayuki Hino ◽  
...  
Keyword(s):  
Group Performance ◽  
International Prognostic Index ◽  
Eastern Cooperative Oncology Group ◽  
Prognostic Index ◽  
Data Monitoring Committee ◽  
B Cell Lymphoma ◽  
Phase Iii ◽  
First Line ◽  
Double Blind ◽  
Poor Risk

TPS8118 Background: Effective DLBCL adjuvant therapy after first-line chemotherapy is needed as high-risk DLBCL is associated with a poor 4-year overall survival (OS) rate (Sehn et al, Blood 2007;109:1857-61). In a phase II study of the oral mammalian target of rapamycin inhibitor everolimus in relapsed, aggressive non-Hodgkin lymphoma, DLBCL patients (n=47) had a 30% overall response rate (Witzig et al, Leukemia 2011;25:341-7). Methods: PILLAR-2 is an ongoing international, randomized, double-blind, phase 3 study designed to compare everolimus efficacy and safety with that of placebo in poor-risk DLBCL patients who achieved complete response (CR) with first-line rituximab-based chemotherapy (R-chemo) (ClinicalTrials.gov: NCT00790036; sponsor: Novartis Pharmaceuticals). Eligibility criteria include age ≥18 years; confirmed stage II bulky, III, or IV DLBCL and International Prognostic Index 3-5 at diagnosis; confirmed CR per revised International Workshop Response Criteria for malignant lymphoma (Cheson et al, J Clin Oncol 2007;25:579-86) after first-line R-chemo regimen completed 6-14 weeks before study drug start; Eastern Cooperative Oncology Group performance status ≤2; no ongoing or post–R-chemo radiation; and no myelosuppressive chemotherapy or biologic therapy within 3 weeks. Patients are randomized 1:1 to everolimus 10 mg once daily or matching placebo and treated for 12 months or until disease relapse, unacceptable toxicity, or death. Radiologic tumor assessment is performed at baseline, every 12 weeks during years 1 and 2, every 24 weeks during years 3 and 4, and annually thereafter until start of new anticancer therapy or 5 years after last patient randomization. The primary endpoint is disease-free survival (DFS). Secondary endpoints are OS, lymphoma-specific survival, and safety. Expected enrollment is 687 patients. Final analysis will be performed when 279 DFS events occur; survival follow-up will continue until 338 deaths occur and the last randomized patient has been followed for ≥5 years. Currently, 422 patients are enrolled. The data monitoring committee last reviewed the trial in July 2011 and recommended that it continue as planned.

A multi-institutional feasibility study of S-1/oxaliplatin (SOX) plus bevacizumab in patients with advanced/metastatic colorectal cancer: HiSCO-02 prospective phase II study.

2015 ◽  
Vol 33 (3_suppl) ◽  
pp. 728-728
Author(s):  
Manabu Kurayoshi ◽  
Katsunori Shinozaki ◽  
Takao Hinoi ◽  
Tsuyoshi Kobayashi ◽  
Manabu Shimomura ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Phase Ii ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Dose Intensity ◽  
Sensory Neuropathy ◽  
Standard Regimen ◽  
Promising Alternative

728 Background: mFOLFOX6 regimen, which is a standard regimen for metastatic colorectal cancer (CRC), is inconvenient owing to its requirement for continuous infusion via vascular access. We aimed to investigate the efficacy and safety of S-1/oxaliplatin (SOX) plus bevacizumab, a promising alternative treatment to replace mFOLFOX6. Methods: We undertook a clinical phase II trial in 12 institutions in Hiroshima, Japan. We enrolled individuals aged 20–80 years who had metastatic CRC, had an Eastern Cooperative Oncology Group performance status (PS) of 0 or 1, had assessable lesions, and had received no previous chemotherapy. Eligible patients were assigned SOX plus bevacizumab (S-1: 80-120 mg/body/day, day 1–14 orally administrated, oxaliplatin: 130mg/m2 day 1 i.v., bevacizumab: 7.5mg/kg day 1 i.v. q3w). The primary endpoint was response rate (RR), and the secondary end points were progression-free survival (PFS), overall survival (OS), and safety. Results: From May 2011 to January 2014, 55 patients (mean age, 64 years) were enrolled. The number of metastatic organs were one: 29 cases (52.7%), two or more: 25 cases (45.4%), and 2 cases had no target lesions (3.6%). Median follow up time was 12.8 months (range, 1.4-38.6 months). RR was 45.4% (95% CI, 32.2%-58.6%) and disease control rate was 87.3% (95% CI, 78.5-96.1%). Median PFS and OS time were 9.2 months (95% CI, 7.6-10.8) and 22.0 months (95% CI, 17.7-26.2), respectively. The median number of cycles of chemotherapy was 7 (range, 1-16). The median relative dose intensity of oxaliplatin, S-1, and bevacizumab were 85%, 85%, and 87%, respectively. Major toxic effects (grade 3/4) were thrombocytopenia (5.7%), neutropenia (7.5%), sensory neuropathy (13.2%), and anorexia (17.0%). Conclusions: These data indicated that the SOX plus bevacizumab regimen is effective and well tolerated in patients with metastatic CRC. Clinical trial information: UMIN000004976.

CHOP Alone Compared With CHOP Plus Radiotherapy for Localized Aggressive Lymphoma in Elderly Patients: A Study by the Groupe d’Etude des Lymphomes de l’Adulte

2007 ◽  
Vol 25 (7) ◽  
pp. 787-792 ◽  
Author(s):  
Christophe Bonnet ◽  
Georges Fillet ◽  
Nicolas Mounier ◽  
Gérard Ganem ◽  
Thierry Jo Molina ◽  
...  
Keyword(s):  
Overall Survival ◽  
Elderly Patients ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Low Risk ◽  
Aggressive Lymphoma ◽  
Treatment Groups ◽  
Involved Field ◽  
To Receive

Purpose Chemoradiotherapy has been considered standard treatment for patients with limited-stage aggressive lymphoma on the basis of trials conducted before the introduction of the International Prognostic Index. To evaluate this approach in elderly patients with low-risk localized lymphoma, we conducted a trial comparing chemoradiotherapy with chemotherapy alone. Patients and Methods Previously untreated patients older than 60 years with localized stage I or II histologically aggressive lymphoma and no adverse prognostic factors of the International Prognostic Index were randomly assigned to receive either four cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus involved-field radiotherapy (299 patients) or chemotherapy alone with four cycles of CHOP (277 patients). Results With a median follow-up time of 7 years, event-free and overall survival did not differ between the two treatment groups (P = .6 and P = .5, respectively). The 5-year estimates of event-free survival were 61% for patients receiving chemotherapy alone and 64% for patients receiving CHOP plus radiotherapy; the 5-year estimates of overall survival were 72% and 68%, respectively. In a multivariate analysis, overall survival was affected by stage II disease (P < .001) and male sex (P = .03). Conclusion In this large prospective study, CHOP plus radiotherapy did not provide any advantage over CHOP alone for the treatment of low-risk localized aggressive lymphoma in elderly patients.

scholarly journals Clinical analysis of ECOG PS and adverse reactions in patients with anlotinib at advanced NSCLC as the third or further line treatment: a retrospective observational study

2020 ◽  
Author(s):  
wei guo gu ◽  
MingBin Hu ◽  
JianXiong Deng ◽  
Feng Qiu
Keyword(s):  
Adverse Reactions ◽  
Advanced Nsclc ◽  
Group Performance ◽  
Remission Rate ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Lung Squamous Cell Carcinoma ◽  
Clinical Analysis ◽  
Line Treatment ◽  
Ecog Ps

Abstract Background: Previous studies have shown that anlotinib be a decent choice in third- or futher line treatment of advanced NSCLC. However, the study anslysis of relationship between Eastern Cooperative Oncology Group performance status(ECOG PS) and adverse reactions in advanced NSCLC with anlotinib therapy is less. Methods: We evaluated the efficacy and toxicity of anlotinib in patients with previously treated advanced NSCLC from June 2018 to March 2019. Survival analysis was performed by the Kaplan–Meier method.Results: According to ECOG PS devided into PS 0-1 group(n=63) and PS 2 group(n=28) . The PS 0-1 of median progression-free survival (mPFS, 5.5 vs.2.7 months, P＜0.05) , overall survival (mOS, 9.2 vs.4.7 months，P＜0.05) was longer than PS 2. The PS 0-1 of objective remission rate(ORR, 45.1% vs 6.6%), disease control rate(DCR, 8.8% vs 1.1%) was significanly more than PS 2. The PS 0-1 group of I-II adverse reactions was high than PS 2 group(52.3% vs 32.1%), but the III-IV adverse reactions were less than PS 2 group(9.5% vs 10.7%). Moreover, multivariate analysis indicated that PS was independent risk factor of PFS（HR=2.816, 95%CI：1.661-4.773，P<0.0001）as well as OS(HR=3.188, 95%CI：1.789-5.682，P=0.0001) for anlotinib therapy in NSCLC. Conclusions: Patients in advanced NSCLC with PS 0–1 get better PFS and OS than PS 2 followed by anlotinib treatment in NSCLC. Advanced lung squamous cell carcinoma(LUSC) recived anlotinib treatment with the same efficacy comparable to adenocarcinoma, and patients with PS 0-1 may benefit the most than PS 2.

scholarly journals Myosteatosis as a novel prognostic biomarker after radical cystectomy for bladder cancer

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Shimpei Yamashita ◽  
Yuya Iwahashi ◽  
Haruka Miyai ◽  
Takashi Iguchi ◽  
Hiroyuki Koike ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Cox Regression ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Psoas Muscle ◽  
Hounsfield Units ◽  
Computed Tomography Images ◽  
Psoas Muscles

AbstractThis study aims to evaluate the influence of myosteatosis on survival of patients after radical cystectomy (RC) for bladder cancer. We retrospectively identified 230 patients who underwent RC for bladder cancer at our three institutions between 2009 and 2018. Digitized free-hand outlines of the left and right psoas muscles were made on axial non-contrast computed tomography images at level L3. To assess myosteatosis, average total psoas density (ATPD) in Hounsfield Units (HU) was also calculated as an average of bilateral psoas muscle density. We compared cancer-specific survival (CSS) between high ATPD and low ATPD groups and performed cox regression hazard analyses to identify the predictors of CSS. Median ATPD was 44 HU (quartile: 39–47 Hounsfield Units). Two-year CSS rate in overall patients was 76.6%. Patients with low ATPD (< 44 HU) had significantly lower CSS rate (P = 0.01) than patients with high ATPD (≥ 44 HU). According to multivariate analysis, significant independent predictors of poor CSS were: Eastern Cooperative Oncology Group performance status ≥ 1 (P = 0.03), decreasing ATPD (P = 0.03), non-urothelial carcinoma (P = 0.01), pT ≥ 3 (P < 0.01), and pN positive (P < 0.01). In conclusion, myosteatosis (low ATPD) could be a novel predictor of prognosis after RC for bladder cancer.

scholarly journals Clinical characteristics and outcomes of primary versus secondary gastrointestinal mantle cell lymphoma

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Alessia Castellino ◽  
Aung M. Tun ◽  
Yucai Wang ◽  
Thomas M. Habermann ◽  
Rebecca L. King ◽  
...  
Keyword(s):  
Mantle Cell Lymphoma ◽  
Cell Lymphoma ◽  
Performance Status ◽  
International Prognostic Index ◽  
Prognostic Index ◽  
Local Therapy ◽  
Progression Free Survival ◽  
Cell Transplant ◽  
Multiple Lesions ◽  
Mantle Cell

AbstractPrimary gastrointestinal (GI) mantle cell lymphoma (MCL) is rare and the optimal management is unknown. We reviewed 800 newly diagnosed MCL cases and found 22 primary (2.8%) and 79 (9.9%) secondary GI MCL cases. Age, sex, and performance status were similar between primary and secondary cases. Secondary cases had more elevations in lactate dehydrogenase (28% vs 0%, P = 0.03) and a trend for a higher MCL international prognostic index (P = 0.07). Observation or local therapy was more common for primary GI MCL (29% vs 8%, P < 0.01), and autologous stem-cell transplant was more common for secondary GI MCL (35% vs 14%, P < 0.05). The median follow-up was 85 months. Primary and secondary GI MCL had similar 5-year progression-free survival (PFS) (30% vs 28%, P = 0.59) and overall survival (OS) (65% vs 66%, P = 0.83). The extent of GI involvement in primary GI MCL affected treatment selection but not outcome, with a 5-year PFS of 43% vs 14% vs 31% (P = 0.48) and OS of 57% vs 71% vs 69% (P = 0.54) in cases with single lesion vs multiple lesions in 1 organ vs multiple lesions in ≥2 organs. Less aggressive frontline treatment for primary GI MCL is reasonable. It is unknown whether more aggressive treatment can result in improved outcomes.

scholarly journals Effectiveness and Safety of Immune Checkpoint Inhibitors for Patients with Advanced Non Small-Cell Lung Cancer in Real-World: Review and Meta-Analysis

Cancers ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 1388
Author(s):  
Manlio Mencoboni ◽  
Marcello Ceppi ◽  
Marco Bruzzone ◽  
Paola Taveggia ◽  
Alessia Cavo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Real World ◽  
Group Performance ◽  
Checkpoint Inhibitors ◽  
Meta Analysis ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Small Cell ◽  
Small Cell Lung ◽  
Eligibility Criteria

Immunotherapy based on anti PD-1/PD-L1 inhibitors is the new standard of advanced non-small cell lung cancers. Pembrolizumab, nivolumab and atezolizumab are used in clinical practice. The strict eligibility criteria of clinical trials do not allow researchers to fully represent treatment effects in the patients that will ultimately use these drugs. We performed a systematic review and a meta-analysis to evaluate the effectiveness and safety of these drugs, and more generally of ICIs, as second-line therapy in NSCLC patients in real world practice. MEDLINE, PubMed, Scopus and Web of Science were searched to include original studies published between January 2015 and April 2020. A total of 32 studies was included in the meta-analysis. The overall radiological response rate (ORR), disease control rate (DCR), median progression-free survival (PFS) and overall survival (OS) were 21%, 52%, 3.35 months and 9.98 months, respectively. The results did not change when analysis was adjusted for Eastern Cooperative Oncology Group performance status (ECOG PS) and age. A unitary increase in the percent of patients with liver and CNS metastases reduced the occurrence of DCR by 7% (p < 0.001) and the median PFS by 2% (p = 0.010), respectively. The meta-analysis showed that the efficacy and safety of immunotherapy in everyday practice is comparable to that in clinical trials.

scholarly journals Definitive carbon ion radiotherapy for tracheobronchial adenoid cystic carcinoma: a preliminary report

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Jian Chen ◽  
Jingfang Mao ◽  
Ningyi Ma ◽  
Kai-Liang Wu ◽  
Jiade Lu ◽  
...  
Keyword(s):  
Adenoid Cystic Carcinoma ◽  
Group Performance ◽  
Primary Tumour ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Tumour Response ◽  
Carbon Ion Radiotherapy ◽  
Rare Tumour ◽  
Carbon Ion ◽  
Adenoid Cystic

Abstract Background Tracheobronchial adenoid cystic carcinoma (TACC) is a rare tumour. About one-third of patients miss their chance of surgery or complete resection as it is mostly detected in the advanced stage; hence, photon radiotherapy (RT) is used. However, the outcomes of photon RT remain unsatisfactory. Carbon ion radiotherapy (CIRT) is thought to improve the therapeutic gain ratio; however, the outcomes of CIRT in TACC are unclear. Therefore, we aimed to assess the effects and toxicities of CIRT in patients with TACC. Methods The inclusion criteria were as follows: 1) age 18–80 years; 2) Eastern Cooperative Oncology Group Performance Status 0–2; 3) histologically confirmed TACC; 4) stage III–IV disease; 5) visible primary tumour; and 6) no previous RT history. The planned prescription doses of CIRT were 66–72.6 GyE/22–23 fractions. The rates of overall survival (OS), local control (LC), and progression-free survival (PFS) were calculated using the Kaplan-Meier method. Treatment-induced toxicities and tumour response were scored according to the Common Terminology Criteria for Adverse Events and Response Evaluation Criteria in Solid Tumors, respectively. Results Eighteen patients with a median age of 48 (range 30–73) years were enrolled. The median follow-up time was 20.7 (range 5.8–44.1) months. The overall response rate was 88.2%. Five patients developed lung metastasis after 12.2–41.0 months and one of them experienced local recurrence at 31.9 months after CIRT. The rates of 2-year OS, LC, and PFS were 100, 100, and 61.4%, respectively. Except for one patient who experienced grade 4 tracheal stenosis, which was relieved after stent implantation, no other ≥3 grade toxicities were observed. Conclusions CIRT might be safe and effective in the management of TACC based on a short observation period. Further studies with more cases and longer observation are warranted.

Phase II Trial of the Combination of Bevacizumab and Erlotinib in Patients Who Have Advanced Hepatocellular Carcinoma

2009 ◽  
Vol 27 (6) ◽  
pp. 843-850 ◽  
Author(s):  
Melanie B. Thomas ◽  
Jeffrey S. Morris ◽  
Romil Chadha ◽  
Michiko Iwasaki ◽  
Harmeet Kaur ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Response Rate ◽  
Group Performance ◽  
Performance Status ◽  
Eastern Cooperative Oncology Group ◽  
Evaluation Criteria ◽  
Progression Free Survival ◽  
Advanced Hepatocellular Carcinoma ◽  
Study Objective ◽  
Advanced Hcc

Purpose The study objective was to determine the proportion of patients with hepatocellular carcinoma (HCC) treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16-week progression-free survival [PFS16]) of continuous therapy. Secondary objectives included response rate, median PFS, survival, and toxicity. Patients and Methods Patients who had advanced HCC that was not amenable to surgical or regional therapies, up to one prior systemic treatment; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28-day cycles. Tumor response was evaluated every 2 cycles by using Response Evaluation Criteria in Solid Tumors Group criteria. A total of 40 patients were treated. Results The primary end point of PFS16 was 62.5%. Ten patients achieved a partial response for a confirmed overall response rate (intent-to-treat) of 25%. The median PFSevent was 39 weeks (95% CI, 26 to 45 weeks; 9.0 months), and the median overall survival was 68 weeks (95% CI, 48 to 78 weeks; 15.65 months). Grades 3 to 4 drug-related toxicity included fatigue (n = 8; 20%), hypertension (n = 6; 15%), diarrhea (n = 4; 10%) elevated transaminases (n = 4; 10%), gastrointestinal hemorrhage (n = 5; 12.5%), wound infection (n = 2; 5%) thrombocytopenia (n = 1; 2.5%), and proteinuria, hyperbilirubinemia, back pain, hyperkalemia, and anorexia (n = 1 each). Conclusion The combination of B + E in patients who had advanced HCC showed significant, clinically meaningful antitumor activity. B + E warrant additional evaluation in randomized controlled trials.

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