Low-dose gemcitabine and paclitaxel combination therapy as second- or third-line treatment in patients with advanced urothelial cancer: Pain relief and tolerability.

310 Background: Pain is the most devastating symptom of advanced urothelial cancer (UC). In addition, analgesics often decrease quality of life. So, pain relief and reduction of dosage are important goals for patients with such advanced UC. Cisplatin (CDDP)-containing chemotherapy is most effective regimen in patients with metastatic or recurrent UC. On the other hand, there is no established regimen for advanced UC after CDDP-containing chemotherapy. We performed low-dose combined therapy of gemcitabine (GEM) and paclitaxel (PTX), named GP therapy, as second- or third-line treatment for these patients. Methods: Thirty-three patients with metastatic and/or recurrent urothelial cancer (upper urinary tract = 13 and bladder =20 patients) previously treated with CDDP-containing chemotherapy were treated with GP therapy (GEM = 70 mg/m2 and PTX = 700 mg/m2 on day 1 and 8, repeated every 28 days). Survival was calculated from judgment of tumor progression. Pain was measured on a visual analog scale of 0–10. Positive effects for pain relief were defined as a decrease in analgesic consumption or a decrease in pain grade according to the visual analog scale, without increasing the dose of analgesics. Regulation of analgesics was performed by independent team that did not know this study. Pain relief and survival were compared with other chemotherapy (control; GEM alone = 9 and PTX-based chemotherapy except for GP therapy = 14). Results: At the start of this treatment, 31 patients had abdominal or back pain due to UC. In addition, 3 patients also had bone pain of metastatic tumors. In GP therapy, 28 patients (84.8%) were judged as positive in pain and only 1 patient needed to increase analgesics. On the other hand, control group showed 13 of 23 patients (56.5%) were stable and 7 (30.4%) were judged as positive in pain. Kaplan-Meier survival curves showed overall survival periods in patients with GP therapy were better compared to control group (p=0.023). All patients were received in the outpatient setting because severe side effect was not occurred. Conclusions: Low-dose GP therapy is feasible and well-tolerated as second/third-line chemotherapy in patients with advanced UC.

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Randomized phase III trial of pixantrone compared with other chemotherapeutic agents for third-line single-agent treatment of relapsed aggressive non-Hodgkin's lymphoma

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.8523 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 8523-8523

Author(s):

R. Pettengell ◽

G. Narayanan ◽

F. H. Mendoza ◽

R. Digumarti ◽

H. Gomez ◽

...

Keyword(s):

Single Agent ◽

Chemotherapeutic Agents ◽

Phase Iii ◽

Study Endpoint ◽

Primary Study ◽

Control Group ◽

Line Treatment ◽

Phase Ii Studies ◽

Third Line ◽

Third Line Treatment

8523 Background: Currently, treatment options for multiply relapsed aggressive NHL are limited, and response rates are disappointing. Pixantrone, a novel aza-anthracenedione with structural similarities to mitoxantrone, has potentially reduced cardiotoxicity and has demonstrated promising clinical activity in phase II studies in heavily pretreated NHL patients. Methods: PIX301 was a controlled, multicenter, open-label phase III study of ≥ third-line treatment of relapsed aggressive (de novo or transformed) NHL. All patients were required to have received ≥ 1 prior anthracycline-containing regimen, with the cumulative doxorubicin-equivalent dose limited to ≤ 450 mg/m2. Randomization was to pixantrone 85 mg/m2 on days 1, 8 and 15 of 28-day cycles, for up to 6 cycles, or to investigator's choice of a single-agent comparator (vinorelbine, oxaliplatin, ifosfamide, etoposide, or mitoxantrone; in the US only, gemcitabine and rituximab were permitted). The primary study endpoint was CR/CRu rate. Secondary objectives included safety, OS, and ORR. Originally planned to enroll 320 patients, PIX301 was amended to 140 patients due to slow enrollment. Results: 140 patients (70 per arm) were randomized. Median age was 60 on the pixantrone arm, 58 on the control arm; patients on both arms had received a median of 3 prior chemotherapeutic regimens. Based on independent review in the ITT population, the CR/CRu rate in patients treated with pixantrone was significantly higher than in those receiving other agents (20.0% vs. 5.7%, p-value = 0.02), and there were no CRs in the control group compared to 8 CRs in the pixantrone group. Conclusions: In this study, single-agent therapy with pixantrone achieved significantly superior CR/CRu and ORR rates in ≥ third-line treatment of relapsed/refractory aggressive NHL. [Table: see text] No significant financial relationships to disclose.

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Safety And Efficacy of ICIs Plus Anlotinib Vs Anlotinib Alone As Third-Line Treatment In Extensive-Stage Small Cell Lung Cancer: A Retrospective Study

10.21203/rs.3.rs-793454/v1 ◽

2021 ◽

Author(s):

Qing Chen ◽

Yan Li ◽

Wenjie Zhang ◽

Chen Wang ◽

Shengjie Yang ◽

...

Keyword(s):

Adverse Events ◽

Small Cell ◽

Control Group ◽

Observation Group ◽

Line Treatment ◽

Small Cell Lung ◽

Extensive Stage ◽

Third Line ◽

And Control ◽

Third Line Treatment

Abstract Purpose: The objective of this study was to evaluate safety and efficacy of Immune checkpoint inhibitors (ICIs) plus anlotinib as third-line treatment in extensive-stage small cell lung cancer (ES-SCLC).Methods: 120 patients with ES-SCLC admitted to Shandong Cancer Hospital between January 2019 and December 2020, were retrospectively analyzed. They were divided into observation group (n=62) and control group (n=58) according to different treatment plans. Observation group were given ICIs plus anlotinib, while control group were given anlotinib alone. The primary endpoint of the study was progression free survival (PFS), and the secondary endpoints were objective response rate (ORR) and disease control rate (DCR). Efficacy evaluation was carried out every 2 cycles of the treatment. Univariate and multivariate analyses were performed to determine the prognostic factors. The main adverse events were evaluated according to the Common Terminology Criteria for Adverse Events version 5.0.Results: In observation group and control group, the DCR were 87.1% and 72.4% (p = 0.044), and the ORR were 19.4% and 6.9% (p = 0.045), respectively. The median PFS was longer in observation group (7.53 months) than that in control group (4.57 months) (p = 0.0033). In Cox regression analysis, the Eastern Cooperative Oncology Group performance status score, brain metastases and metastatic sites were prognostic factors of ICIs plus anlotinib. Compared with control group, Grade 3-4 adverse events did not increase significantly in observation group. Treatment-related adverse events were tolerable and controllable.Conclusion: ICIs plus anlotinib showed promising efficacy and low toxicity in third-line treatment of ES-SCLC.

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Safety and efficacy of ICI plus anlotinib vs. anlotinib alone as third-line treatment in extensive-stage small cell lung cancer: a retrospective study

Journal of Cancer Research and Clinical Oncology ◽

10.1007/s00432-021-03858-2 ◽

2021 ◽

Author(s):

Qing Chen ◽

Yan Li ◽

Wenjie Zhang ◽

Chen Wang ◽

Shengjie Yang ◽

...

Keyword(s):

Lung Cancer ◽

Small Cell ◽

Control Group ◽

Observation Group ◽

Line Treatment ◽

Small Cell Lung ◽

Safety And Efficacy ◽

Extensive Stage ◽

Third Line ◽

Third Line Treatment

Abstract Purpose The objective of this study was to evaluate the safety and efficacy of immune checkpoint inhibitor (ICI) plus anlotinib as third-line treatment in extensive-stage small cell lung cancer (ES-SCLC). Methods A total of 120 patients with ES-SCLC who were admitted to Shandong Cancer Hospital between January 2019 and December 2020 were retrospectively analyzed. They were divided into the observation group (n = 62) and the control group (n = 58) according to their different treatment plans. The observation group was given ICI plus anlotinib, while the control group was given anlotinib alone. The primary endpoint of the study was progression-free survival (PFS), and the secondary endpoints were the objective response rate (ORR) and disease control rate (DCR). An efficacy evaluation was carried out every 6 weeks. Univariate and multivariate analyses were performed to identify the prognostic factors. The main treatment-related adverse events were evaluated according to the Common Terminology Criteria for Adverse Events version 5.0. Results In the observation group and the control group, the DCRs were 87.1% and 72.4% (p = 0.044), and the ORRs were 19.4% and 6.9% (p = 0.045), respectively. The median PFS was longer in the observation group (7.5 months) than in the control group (4.6 months) (p = 0.0033). In Cox regression analysis, the Eastern Cooperative Oncology Group performance status score, brain metastases and metastatic sites were prognostic factors of ICI plus anlotinib. Compared with the control group, grade 1–2 immune-related pneumonia and hypothyroidism of patients in the observation group were significantly increased (p < 0.05), but grade 3–4 treatment-related adverse reactions were not significantly increased (p > 0.05). Conclusion ICI plus anlotinib showed promising efficacy and manageable toxicity in third-line treatment of ES-SCLC.

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