Maintenance Chemotherapy In Patients Research Articles

Maintenance Chemotherapy in Patients with Platinum-Sensitive Relapsed Epithelial Ovarian Cancer after Second-Line Chemotherapy.

(1) Background: Our aim was to evaluate the efficacy and adverse effects of maintenance chemotherapy in platinum-sensitive recurrent epithelial ovarian cancer after second-line chemotherapy. (2) Methods: A total of 72 patients from a single institute who had been diagnosed with platinum-sensitive recurrent ovarian cancer and had experienced either complete or partial response after six cycles of second-line chemotherapy were divided into a standard group (n = 31) with six cycles or a maintenance group (n = 41) with more than six cycles. We then compared patient characteristics and survival outcomes between these two groups. (3) Results: In all patients, after primary management for the first recurrence, the maintenance group showed worse survival outcomes. Patients who had not undergone either surgery or radiotherapy were divided into complete response and partial response groups after six cycles of chemotherapy. In patients with partial response, maintenance chemotherapy led to a significant improvement in PFS (median, 3.6 vs. 6.7 months, p = 0.007), but no significant change in in OS. The median cycle number of maintenance chemotherapy was four. (4) Conclusions: Maintenance chemotherapy may still play an important role in patients with platinum-sensitive recurrent ovarian cancer, particularly in selected patient groups.

Maintenance Chemotherapy for Patients with Rhabdomyosarcoma.

Maintenance chemotherapy (MC) defines the administration of prolonged relatively low-intensity chemotherapy with the aim of "maintaining" tumor complete remission. This paper aims to report an update of the RMS2005 trial, which demonstrated better survival for patients with high-risk localized rhabdomyosarcoma (RMS) when MC with vinorelbine and low-dose cyclophosphamide was added to standard chemotherapy, and to discuss the published experience on MC in RMS. In the RMS2005 study, the outcome for patients receiving MC vs. those who stopped the treatment remains superior, with a 5-year disease-free survival of 78.1% vs. 70.1% (p = 0.056) and overall survival of 85.0% vs. 72.4% (p = 0.008), respectively. We found seven papers describing MC in RMS, but only one randomized trial that did not demonstrate any advantage when MC with eight courses of trofosfamide/idarubicine alternating with trofosfamide/etoposide has been employed in high-risk RMS. The use of MC showed better results in comparison to high-dose chemotherapy in non-randomized studies, including metastatic patients, and demonstrated feasibility and tolerability in relapsed RMS. Many aspects of MC in RMS need to be investigated, including the best drug combination and the optimal duration. The ongoing EpSSG trial will try to answer some of these questions.

Metronomic oral maintenance chemotherapy in patients with localized high-risk rhabdomyosarcoma (RMS) and RMS-like tumors: A report from a randomized, multicenter, phase III trial CWS-2007HR.

10033 Background: Low dose maintenance therapy as consolidation after multimodal standard therapy has been shown to improve survival in patients with sarcoma. It is however unclear which drugs and how long would be optimal. We investigated whether adding oral maintenance chemotherapy after standard multimodal therapy (ST) in patients with localized RMS and RMS-like sarcoma defined as high and very-high risk (HR and VHR), according to CWS stratification, would improve survival. Methods: Patients (pts) age > 6 months < 21 years, with 1. embryonal RMS N0, incompletely resected, (Group II or III), tumor size > 5cm and/or ≥10 years, in unfavorable primary sites and all N1 (HR RMS Group), 2. alveolar RMS N0/N1 (VHR RMS Group) 3.Unidfferentiated sarcoma (UDS), extraskeletal Ewing sarcoma (EES) and primary non resectable (Group III) synovial sarcoma (SS) (HR RMS-like Group) in complete remission after ST including 9 cycles of ifosfamide, vincristine and actinomycin D +/- doxorubicin, surgery and/or radiotherapy were eligible for randomization to stop treatment (S-arm) or receive maintenance chemotherapy (M-arm) with eight 10-days courses consisting of trofosfamide (2x 75mg/m²/day) and idarubicine (1 x 5mg/m²/day 1,4,7,10) alternating with trofosfamide and etoposide (2x 25mg/m²/day). The study was designed with 80% power and a two-sided alpha level of 5% to detect an increase in 3 yr EFS from 60 to 75%. Randomisation was stratified according to risk groups. To reduce possible imbalances in the number of treatment assignments, a permuted block design was used. The initial calculated sample size was 145 pts in each group (recruitment period six years). Due to the lower than planned recruitement rate, the accrual was extended to 10 years and sample size recalculated to 98 pts in each group. Results: Between 1.7.2009 and 30.6.2019, 441 pts were eligible at diagnosis and 337 at the end of ST. 195 pts were randomized: 99 were assigned to the S-arm and 96 to M-arm. The distribution of the following clinical features:age, gender, tumor size, IRS-Group, T-Status, N-Status, histology and localisation showed no significant difference between the treatment groups. In the intent to treat population, with a median follow up of 4.9 years (IQR 3.0-5.7) in surviving pts, 3yr EFS and OS in M-arm vs S-arm were respectively: EFS 66.2% (95% IC 57.1-76.79) vs 75.0% (95% IC 66.8-84.3) (p 0.07) and OS 81.9% (95% IC 74.2-90.4) vs 84.6 (95% IC 77.5-92.4) (p 0.15). Toxicity grade 3 (no grade 4) in the M-arm was: hematological in 51 %, febrile infection 5%, sensory neuropathy in 1% pts. Conclusions: The addition of maintenance therapy with trofosfamide, etoposide and idarubicine after ST does not improve EFS and OS in patients with high risk RMS and RMS-like sarcomas. Clinical trial information: 2007-0001478-10.

The prognostic and predictive significance of cytokeratin 5/6 and epidermal growth factor receptor in metastatic triple-negative breast cancer treated with maintenance capecitabine.

BackgroundCapecitabine is the most widely used agent for maintenance chemotherapy in patients with metastatic triple-negative breast cancer (mTNBC). However, there are no biomarkers for identifying mTNBC patients who could benefit from capecitabine maintenance.MethodsThe prognostic roles of cytokeratin 5/6 (CK5/6), epidermal growth factor receptor (EGFR), and maintenance therapy were evaluated in mTNBC patients. Both CK5/6 and EGFR were detected using immunohistochemistry. Of 115 patients who achieved disease control, 56 received capecitabine maintenance therapy and 59 underwent observation. The progression-free survival (PFS) and overall survival (OS) of the patients were evaluated.ResultsThe median PFS and OS were longer in the maintenance group than that in the observation group (7.3 versus 5.7 months, P=0.0016; 22.4 versus 17.9 months, P=0.0055). Patients with basal-like TNBC had a poorer survival times than in those with non-basal-like TNBC (P=0.0062). Capecitabine maintenance significantly prolonged the OS of non-basal-like TNBC patients (P=0.0257), while in the basal-like TNBC patients, the difference was not significant (P=0.0541). Multivariate analysis revealed that the prolonged OS was related to age >50 years (P=0.005), presence of visceral metastases (P=0.035), response to initial therapy (P=0.017), maintenance therapy (P=0.033), and CK5/6 and EGFR status (P=0.032). Compared with the observation group, toxicities of all grades were more frequently observed in the maintenance group, including neutropenia, 85.71% vs. 25.87%, P<0.001; thrombocytopenia, 55.36% vs. 11.86%, P<0.001; anemia, 82.14% vs. 52.54%, P= 0.001; nausea 83.47% vs. 11.86%, P<0.001; vomiting 69.64% vs. 8.47%, P<0.001; and hand-foot syndrome (HFS) 32.14% vs. 1.69%, P<0.001.ConclusionsOur study revealed that patients with non-basal-like TNBC had a better clinical outcome than those with basal-like TNBC, and capecitabine maintenance treatment significantly prolonged PFS and OS in patients with TNBC. Patients with non-basal-like TNBC could benefit from maintenance therapy with capecitabine and CK5/6 and EGFR are biomarkers for TNBC prognosis.

Abstract GS3-02: Durvalumab compared to maintenance chemotherapy in patients with metastatic breast cancer: Results from phase II randomized trial SAFIR02-IMMUNO

Abstract Background : While treatment with anti-PDL1 improves outcome in combination with chemotherapy in patients with metastatic triple negative breast cancer, its efficacy is not explored yet in the context of maintenance therapy after chemotherapy, in a population of Her2-negative metastatic breast cancer. Methods : In SAFIR02 trial (NCT : 02299999), patients are selected to present a Her2-negative metastatic breast cancer eligible to 1st or 2nd line chemotherapy. All patients underwent a biopsy of metastatic disease, followed by targeted sequencing and Oncoscan when &amp;gt;30% cancer cells are present on HES slides. After 6 to 8 cycles of induction chemotherapy, patients who present an actionable genomic alteration are randomized between targeted therapies and continuation of maintenance chemotherapy, and patients without actionable alterations are randomized between durvalumab (dose, schedule) for 2 years and maintenance chemotherapy. As a substudy of the SAFIR02-breast trial, the SAFIR02-IMMUNO trial has its primary endpoint, the PFS, hierarchized as the primary end-point of the core of the study. The plan was to include 190 patients in order to have 80% power using a two-sided logrank test at the 5 % level of significance to detect an improvement from 3 months to 4.76 months corresponding to an HR of 0.63. Results : 191 patients have been randomized between durvalumab and maintenance chemotherapy (190 women) until now, 45.5% TNBC and 53.4% RH+. The median age was 55 years. . 91.6% (175/191) patients were randomized on their first line of chemotherapy in metastatic setting. Median number of metastatic sites at the beginning of the chemotherapy line was 2. PDL1 staining was performed on 89 available tumor FFPE blocks using SP142 antibody. 30% (n=27/89) patients presented a PDL1 positive tumor. PFS and OS will be presented at the conference.Conclusion : This is the first randomized trial comparing aPDL1 inhibitor to chemotherapy in the maintenance setting and to address the question of the efficacy of aPDL1i in HR+/Her2- and triple negative breast cancers. Citation Format: Florence Dalenc, Ingrid Garberis, Thomas Filleron, Amélie Lusque, Thomas Bachelot, Monica Arnedos, Mario Campone, Marie-Paule Sablin, Hervé Bonnefoi, Marta Jimenez, Jacquet Alexandra, Fabrice Andre. Durvalumab compared to maintenance chemotherapy in patients with metastatic breast cancer: Results from phase II randomized trial SAFIR02-IMMUNO [abstract]. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr GS3-02.

Monitoring of cytomegalovirus infection in non-transplant pediatric acute lymphoblastic leukemia patients during chemotherapy.

Cytomegalovirus (CMV) infection is a significant cause of morbidity and mortality in the posttransplant setting; however, it is increasingly recognized in pediatric leukemia during chemotherapy. This study assessed the prevalence and associated factors of CMV infection in pediatric non-transplant leukemia patients.This was a cross-sectional study of 50 pediatric acute lymphoblastic leukemia (ALL) patients receiving chemotherapy at Ramathibodi Hospital from December 2015 to December 2016. CMV viral load quantified by DNA polymerase chain reaction (PCR) was monitored in different phases of chemotherapy: enrolment, post-induction, post-consolidation, post-intensification, and maintenance.One hundred forty one blood tests were evaluated from 50 patients. Overall prevalence of CMV DNAemia (≥20 copies/mL) and high-level CMV DNAemia (≥1000 copies/mL) was 52% (26 of 50) and 16.0% (8 of 50), respectively. All patients with high-level CMV DNAemia were in the maintenance phase of chemotherapy. One patient had CMV retinitis, while the rest had no end-organ CMV diseases. Increased lymphocyte count was significantly associated with protection from high-level CMV DNAemia (odds ratio 0.997, P = .02). Receiver operating characteristic curve identified a cut-off value of 798 cells/mm3 of absolute lymphocyte count (ALC) as a discriminator for the presence of high-level CMV DNAemia (area under the curve 0.756, 95% CI 0.645–0.867, P = .001) with 88.9% sensitivity and 50.4% specificity.CMV infection predominantly occurred during maintenance chemotherapy. Low ALC was significantly associated with high-level CMV DNAemia. CMV infection surveillance by quantitative CMV DNA PCR during maintenance chemotherapy in patients with ALC <800 cells/mm3 may be considered.

Consolidative Radiotherapy for Limited Metastatic Non–Small-Cell Lung Cancer

ImportancePatterns-of-failure studies suggest that in metastatic non–small-cell lung cancer (NSCLC) sites of gross disease at presentation are the first to progress when treated with chemotherapy. This knowledge has led to increased adoption of local ablative radiation therapy in patients with stage IV NSCLC, though prospective randomized evidence is limited.ObjectiveTo determine if intervening with noninvasive stereotactic ablative radiotherapy (SAbR) prior to maintenance chemotherapy in patients with non–progressive limited metastatic NSCLC after induction therapy led to significant improvements in progression-free survival (PFS).Design, Setting, and ParticipantsThis is a single-institution randomized phase 2 study of maintenance chemotherapy alone vs SAbR followed by maintenance chemotherapy for patients with limited metastatic NSCLC (primary plus up to 5 metastatic sites) whose tumors did not possess EGFR-targetable or ALK-targetable mutations but did achieve a partial response or stable disease after induction chemotherapy.InterventionsMaintenance chemotherapy or SAbR to all sites of gross disease (including SAbR or hypofractionated radiation to the primary) followed by maintenance chemotherapy.Main Outcomes and MeasuresThe primary end point was PFS; secondary end points included toxic effects, local and distant tumor control, patterns of failure, and overall survival.ResultsA total of 29 patients (9 women and 20 men) were enrolled; 14 patients (median [range] age, 63.5 [51.0-78.0] years) were allocated to the SAbR-plus-maintenance chemotherapy arm, and 15 patients (median [range] age, 70.0 [51.0-79.0] years) were allocated to the maintenance chemotherapy–alone arm. The trial was stopped to accrual early after an interim analysis found a significant improvement in PFS in the SAbR-plus-maintenance chemotherapy arm of 9.7 months vs 3.5 months in the maintenance chemotherapy–alone arm (P = .01). Toxic effects were similar in both arms. There were no in-field failures with fewer overall recurrences in the SAbR arm while those patients receiving maintenance therapy alone had progression at existing sites of disease and distantly.Conclusions and RelevanceConsolidative SAbR prior to maintenance chemotherapy appeared beneficial, nearly tripling PFS in patients with limited metastatic NSCLC compared with maintenance chemotherapy alone, with no difference in toxic effects. The irradiation prevented local failures in original disease, the most likely sites of first recurrence. Furthermore, PFS for patients with limited metastatic disease appeared similar to those patients with a greater metastatic burden, further arguing for the potential benefits of local therapy in limited metastatic settings.Trial Registrationclinicaltrials.gov Identifier: NCT02045446

W zaawansowanym raku piersi należy kontynuować chemioterapię do czasu progresji

The maintenance chemotherapy in patients with advanced breast cancer is still a matter of controversy. A meta-analysis of 11 randomised trials including phenotypically and therapeutically heterogeneous groups of patients, showed that maintenance chemotherapy prolongs time to progression and survival, and does not affect (but sometimes actually improves) quality of life. However, the decision on treatment duration should take into account the type of chemotherapy, its tolerability and effect, as well as the informed preference of the patient.

Complex decisions for first-line and maintenance treatment of advanced wild-type non-small cell lung cancer.

Until recently, the first-line treatment of advanced non-small cell lung cancer (NSCLC) required minimal clinical decision making. Patients who were eligible for chemotherapy received a platinum-based doublet, and 5-year survival rates were poor. With the advent of molecularly targeted agents and better tolerated chemotherapies--namely, bevacizumab, erlotinib, and pemetrexed--new therapeutic opportunities have emerged. Some of the strategies that have proven to be successful for the treatment of patients with NSCLC are targeting of the vascular endothelial growth factor, use of maintenance chemotherapy for patients without progression of disease after initial therapy, and tailoring of cytotoxic agents specific to the histology of an individual patient's cancer. Each approach has been independently shown to improve overall survival, but integrating the data from a number of complicated trials into the "best" approach for patients remains challenging. This review attempts to address three fundamental questions clinicians face in choosing first-line and maintenance treatment for advanced NSCLC, particularly nonsquamous histology: Is pemetrexed or a taxane agent better for combination with platinum therapy? Should bevacizumab be used, and is it beneficial when added to pemetrexed chemotherapy? When is maintenance therapy indicated, and which agent is best?

First line XELOX chemotherapy combined with subsequent capecitabine maintenance chemotherapy for patients with advanced gastric cancer: a clinical analysis of effectiveness

First line XELOX chemotherapy combined with subsequent capecitabine maintenance chemotherapy for patients with advanced gastric cancer: a clinical analysis of effectiveness

Clinical Benefit of Maintenance Chemotherapy in Patients with Acute Myeloid Leukemia

Background: There is no standard treatment strategy for maintaining first complete remission (CR1) status after several cycles of consolidation chemotherapy in acute myeloid leukemia (AML) patients who are not suitable for transplantation. Maintenance chemotherapy has failed to document the cure rate or prolongation of survivals in patients with acute myeloid leukemia (AML) except for acute promyelocytic leukemia (APL). In this study, we retrospectively compared leukemia free (LFS) and overall survival (OS) of patients with or without maintenance therapy.Methods: Maintenance chemotherapy consisted of daily 6-mercaptopurine and weekly methotrexate per os and lasted for 2 years. Patients who maintained CR1 status after completion of consolidation therapy started maintenance chemotherapy.Results: Fifty two patients (not suitable for transplantation) who completed at least 1 cycle of consolidation therapy were eligible for analysis. Twenty seven patients agreed to administrate oral maintenance chemotherapy whereas 25 patients refused. Median age was 52 years and 24 patients were male. According to the FAB classification, 7.7, 9.6, 40.4, 38.5, 1.9 and 1.9% of patients are AML M0, M1, M2, M4, M6 and M7, respectively. Myelodysplastic syndrome (MDS) related and chemotherapy-related secondary AML patients were 5.6 and 9.6%, respectively. Favorable, intermediate and unfavorable cytogenetic risk groups were 32.7, 63.5 and 2%, respectively. Of 33 patients with intermediate risk, 84.8, 12.1 and 3% were normal karyotype, other not-defined and +8 alone, respectively. Two patients with unfavorable risk were complex karyotype and inv(3). There was no significant difference in the patients’ characteristics between non-maintenance and maintenance group. Almost of all patients (96.4%) received remission induction therapy with a same protocol (7-3 regimen). Relapse was observed in 27 patients (51.9%) after achieving CR1. Median LFS and OS was 28 (95% CI, 2–54) and 29 months (95% CI, 6–52), respectively. The OS was 19 (95% CI, 8–30) and 43 months (95% CI, 19–67) in non-maintenance and maintenance group, respectively (p = 0.044, Fig 1A), whereas LFS was not significantly different. In multivariate analysis, the presence of maintenance therapy was an independent prognostic factor for better LFS (p = 0.044) and OS (p = 0.042, Table 1.). In subgroup analysis (Table 2.)., statistically significant clinical benefit from maintenance chemotherapy was observed in patients with older age (>= 60 years) (p = 0.024), intermediate or unfavorable cytogenetic results (p = 0.004, Fig 1B.), initial higher WBC count (>= 50,000/mm3) (p = 0.005), secondary AML (p = 0.009), and receiving less than 2 cycles of consolidation therapy (p = 0.006).Conclusions: Despite limitation as retrospective analysis with small sample size, our data indicate that maintenance chemotherapy with oral 6-MP and MTX can prolong survivals of patients with AML (except APL) who are not suitable for transplantation as a post-remission therapy particularly with older age, intermediate or unfavorable cytogenetics, initial higher WBC count, secondary AML or receiving less than 2 cycles of consolidation therapy. [Display omitted] [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

SY3-1 - Role of Maintenance Chemotherapy in Non-Elderly Patients with Stage Iv Non-Small Cell Lung Cancer(Nsclc)And a Good Ps

Maintenance chemotherapy for patients with advanced non-squamous NSCLC has been receiving considerable attention because of recent phase III trials demonstrating that maintenance chemotherapy with pemetrexed (PEM) or erlotinib prolonged the overall survival (OS) of patients with advanced NSCLC who did not progress after four cycles of platinum-based chemotherapy. Maintenance chemotherapy consists of two strategies: continuation maintenance and switch maintenance. Continuation maintenance is the continuation of one or more drugs used in the induction regimen. Switch maintenance introduces another agent with no cross-resistance immediately after the completion of induction chemotherapy and is recognized as an early second-line strategy. The success of maintenance chemotherapy requires not only the prolongation of survival but also a good tolerability and the maintenance of QOL. Regarding this point, PEM is considered to be most suitable for maintenance chemotherapy, since PEM produces minimal toxicities when compared with various cytotoxic anticancer agents. Nowadays, continuation maintenance with PEM is recommended after induction chemotherapy with PEM and platinum. On the other hand, switch maintenance chemotherapy has not yet become a standard strategy. A randomized trial comparing switch maintenance with docetaxel (DOC) and standard second-line treatment with DOC demonstrated that the PFS improved significantly (5.7 vs. 2.7 months, P = .0001), but the prolongation of the OS was only marginally significant (median OS: 12.3 vs. 9.7 months, P = .0853). 63% of the patients actually received second-line DOC in the standard arm. The OS for these patients was identical to the OS observed for the switch maintenance arm. Even if patients were followed up carefully, all of them could not always receive second-line chemotherapy because of a deterioration in performance status, etc. Therefore, a switch maintenance strategy might be worth evaluating in future clinical trials.

Results of a randomized prospective clinical trial evaluating maintenance chemotherapy in patients with high-grade, operable osteosarcoma: A report from the Latin American Group of Osteosarcoma Treatment.

10532 Background: Preclinical models show that a daily antiangiogenic regimen at low-dose may be effective against chemotherapy-resistant tumors. In patients (pts) with high grade, operable osteosa...

Duration of chemotherapy for small cell lung cancer: a meta-analysis.

BackgroundMaintenance chemotherapy is widely provided to patients with small cell lung cancer (SCLC). However, the benefits of maintenance chemotherapy compared with observation are a subject of debate.Methodology and Principal FindingsTo identify relevant literature, we systematically searched the Medline, Embase, and Cochrane Central Register of Controlled Trials databases. Eligible trials included patients with SCLC who either received maintenance chemotherapy (administered according to a continuous or switch strategy) or underwent observation. The primary outcome was 1-year mortality, and secondary outcomes were 2-year mortality, overall survival (OS), and progression-free survival (PFS). Of the 665 studies found in our search, we identified 14 relevant trials, which together reported data on 1806 patients with SCLC. When compared with observation, maintenance chemotherapy had no effect on 1-year mortality (odds ratio [OR]: 0.88; 95% confidence interval [CI]: 0.66–1.19; P = 0.414), 2-year mortality (OR: 0.82; 95% CI: 0.57–1.19; P = 0.302), OS (hazard ratio [HR]: 0.87; 95% CI: 0.71–1.06; P = 0.172), or PFS (HR: 0.87; 95% CI: 0.62–1.22; P = 0.432). However, subgroup analyses indicated that maintenance chemotherapy was associated with significantly longer PFS than observation in patients with extensive SCLC (HR, 0.72; 95% CI: 0.58–0.89; P = 0.003). Additionally, patients who were managed using the continuous strategy of maintenance chemotherapy appeared to be at a disadvantage in terms of PFS compared with patients who only underwent observation (HR, 1.27; 95% CI: 1.04–1.54; P = 0.018).Conclusions/SignificanceMaintenance chemotherapy failed to improve survival outcomes in patients with SCLC. However, a significant advantage in terms of PFS was observed for maintenance chemotherapy in patients with extensive disease. Additionally, our results suggest that the continuous strategy is inferior to observation; its clinical value needs to be investigated in additional trials.

Maintenance therapy in breast cancer—many questions remain

A recent clinical trial showed that a significant progression-free and overall survival benefit was associated with maintenance chemotherapy in patients with HER2-negative metastatic breast cancer who have disease control after six cycles of conventional chemotherapy. However, the choice of observation alone as the control arm limits the clinical application of these data.

Three cytotoxic drugs combined with pelvic radiation and as maintenance chemotherapy for patients with squamous cell carcinoma of the anus (SCCA): Long-term follow-up of a phase II pilot study using 5-fluorouracil, mitomycin C and cisplatin

PurposePhase III trials in the 1990s for squamous cell carcinoma of the anus (SCCA) demonstrated 5-fluorouracil (5FU) and mitomycinC (MMC) chemoradiation (CRT) improved outcome compared to radiation (RT) alone, but local recurrence remained significant. This prospective pilot study intensified treatment by integrating 3 cytotoxic drugs into CRT and maintenance chemotherapy. MethodsCRT comprised 5-FU 1000mg/m2 days1–4,29–32, MMC 10mg/m2 day1 and Cisplatin (CDDP) 60mg/m2 days1 and 29, with 45Gy in 25 daily fractions, followed by a 15Gy boost. Maintenance chemotherapy started 4–8weeks later, three courses repeated every 21days, using 5-FU/CDDP doses above, with MMC reduced to 7mg/m2 and administered with the first and third cycles. ResultsIn CRT only 14/19 (74%) patients received protocol-defined chemotherapy doses in week 5. Compliance to maintenance chemotherapy was poor. 15/19 started cycle 1, 13 started cycle 2 and 11 cycle 3. 17/19 experienced G3–G5 toxicity (16 Grade 3/4 and one Grade 5). 16/19 patients (84%) remain alive and disease-free – median follow-up 79months (34–115). ConclusionsDespite favourable results, the significant toxicity and low compliance of the three-drug CRT regimen used, deemed it unsuitable for testing in a phase III trial. A two-drug maintenance regimen was explored in the ACT II trial.

Feasibility Study on Biweekly Paclitaxel Treatment as Maintenance Chemotherapy in Advanced Müllerian Carcinoma

Aim: To evaluate the feasibility of biweekly paclitaxel treatment as maintenance chemotherapy for patients with advanced müllerian carcinoma. Methods: Thirty patients with stage III or IV ovarian, fallopian tube, and peritoneal cancers who underwent primary optimal surgery and standard 6 cycles of carboplatin/taxane-based chemotherapy and exhibited a complete clinical response were entered in this study. Paclitaxel 80 mg/m² was administered biweekly for 12 cycles. Patients were evaluated monthly for treatment-related toxicity. Results: Four patients, including 3 disease progressions and 1 bone marrow suppression, came off the protocol therapy. Twenty-six (86.7%) patients received complete treatment. Although the major toxicity was neutropenia, most of those patients (27/30, 90.0%) did not experience grade 3 or 4 neutropenia. Twenty-four (80.0%) patients showed persistent grade 1 neuropathy and the remaining 6 (20.0%) did not as a result of prior therapy. However, none experienced neuropathy progression during or after the protocol therapy. Most (17/22, 77.3%) of the completely treated patients experienced a regression of symptoms during and after therapy. Conclusion: Biweekly paclitaxel therapy is well tolerated by patients with advanced müllerian carcinoma and is therefore acceptable as a candidate for maintenance chemotherapy in these patients.

Experience with carboplatin and etoposide maintenance chemotherapy in patients with extensive stage small cell lung cancer.

To determine whether maintenance therapy with carboplatin and etoposide improves progression-free and overall survival in patients with extensive stage small cell lung cancer, compared to the standard four to six cycles of cisplatin and etoposide. Forty-two patient records (25 males and 17 females) were retrospectively reviewed in a single community practice. All patients were over the age of 18, with pathologically and radiographically proven extensive stage small cell lung carcinoma (SCLC). The starting doses of chemotherapy were carboplatin, AUC (area under the curve) of 6 IV day 1, and etoposide, 100 mg/m2 IV days 1-3. The regimen was administered every 3 weeks and increased to every 4 to 5 weeks as tolerated or until documented progression occurred. Varying second-line chemotherapies were used. Median overall survival was 17 months from diagnosis, with a progression-free survival of 15 months. Seventy-nine percent of the patients survived more than 10 months. The 1- and 2-year overall survival (OAS) rates were 0.74 (31 patients) and 0.31 (13 patients), respectively. The 1- and 2-year progression free survival (PFS) rates were 0.50 (21 patients) and 0.21 (9 patients), respectively. The improved overall and progression-free survival compared to the current standard in this small single center cohort suggests that maintenance therapy with carboplatin and etoposide to progression may be a prudent area for further investigation in a properly powered randomized, controlled trial.

Maintenance chemotherapy in patients with non-squamous non-small cell lung cancer (NSCLC).

e18146 Background: Maintenance chemotherapy (MCX) has been accepted for non-squamous NSCLC patients (pts) due to overall survival advantage. However, the best MCX (by efficacy and cost) is not yet defined. Prior studies have established the role of pemetrexed (Pem) or bevacizumab (B) as MCX, however, there is not enough data about the combination or the role of single agent Pem as MCX after first-line chemotherapy (FCX) with Pem. The objectives of this study were to evaluate the efficacy of Pem single agent or in combination as MCX for NSCLC pts who have received Pem as FCX. Methods: A retrospective review from January 2008 to November 2009 focused on stage IIIB/IV NSCLC pts who have received or are planned to receive MCX with single agent Pem or in combination (as part of FCX or second line); those whose MCX is part of FCX must also have Pem as FCX. Results: We had19 pts with a median age: 60 years (range, 34-77), 10 males, 11 Hispanic, 6 White, 2 African-American, 17 had adenocarcinoma, 13 had received at least 1 cycle of MCX (median number of MCX cycles: 5; range: 1-18). All chemotherapy regimens were frontline unless otherwise specified: 16 carboplatin/Pem/B (1 pt received it as second line), 1 cisplatin/Pem/B, 1 carboplatin/Pem, and 1 Pem/B (as second line). The best response after completion of FCX (n = 13) was: 2 PR and 11 SD. Eleven of 13 pts on MCX also received Pem as FCX; 12 of these pt. received Pem/B combination and 1 Pem alone as MCX regimen. Two pts on MCX developed grade 3-4 adverse events: fatigue, anemia and thrombocytopenia. One of them died with pneumonia during Pem MCX without disease progression. After a median follow up of 7 months (range: 5-13), no progression of disease has been reported on those pts on MCX. Conclusions: Carboplatin/Pem/B is becoming a common regimen used as FCX followed by MCX Pem/B in eligible patients with non-squamous NSCLC. As MCX, Pem/B is well tolerated with most AEs being grade 1-2. A longer follow up will take place. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Genentech, Lilly

Potential Treatment Options After First-Line Chemotherapy for Advanced NSCLC: Maintenance Treatment or Early Second-Line?

Although substantial progress has been made in the therapeutic options currently available for patients with advanced non-small cell lung cancer (NSCLC), the overall survival profile remains poor for most patients. One of the strategies currently under investigation with the aim of prolonging survival in NSCLC patients is maintenance treatment with either a chemotherapeutic agent or a molecularly targeted agent after first-line chemotherapy. Moreover, this can consist of drugs included in the induction regimen or other noncrossresistant agents. With the currently available data, maintenance treatment with a different noncrossresistant agent (i.e., an early second-line treatment) is perhaps the most promising strategy. The drug chosen for the early second-line treatment should be a well-tolerated agent, considering that patients have just completed a particularly toxic platinum-based chemotherapy. Extending treatment with targeted agents rather than chemotherapy can provide longer progression-free and overall survival times without increasing toxicity. However, at the moment, only progression-free survival has been shown to be consistently superior with maintenance approaches; the evaluation of survival benefits is warranted before defining this strategy as a possible treatment option. Further studies are warranted to establish the role of maintenance chemotherapy in patients with advanced NSCLC.