Long-term results of ERCP- or PTCS-directed photodynamic therapy for unresectable hilar cholangiocarcinoma

Abstract Background Photodynamic therapy (PDT) can be performed as palliative therapy for cholangiocarcinoma, while there is currently insufficient evidence for the efficacy. The aim of this study was to explore the clinical efficacy and safety of endoscopic retrograde cholangiopancreatography (ERCP)- or percutaneous transhepatic cholangioscopy (PTCS)-directed PDT combined with stent placement for unresectable hilar cholangiocarcinoma. Methods A retrospective analysis was conducted on 62 patients with unresectable hilar cholangiocarcinoma. Thirty patients received PDT using hematoporphyrin combined with biliary stent placement (PDT+stent group), including 22 receiving ERCP-directed PDT and 8 receiving PTCS-directed PDT. Survival time, quality of life, and postoperative adverse events were compared to 32 patients receiving biliary stent placement alone (Stent-only group). Results After 42 months of follow-up, median survival time was significantly longer in the PDT+stent group than the Stent-only group (14.2 vs. 9.8 months, P = 0.003). In the PDT+stent group, the median survival time was longer in the 6 patients with recurrence after surgical resection than the 24 patients without prior surgical resection (20.0 vs. 13.0 months, P = 0.017). The QOL total scores was significantly higher in the PDT+stent group than the Stent-only group at postoperative 6, 9, and 12 months (P<0.05). There was no significant difference in the incidence of postoperative adverse events between the two groups (24 [38.7%] vs. 20 [29.0%], P = 0.239). Conclusion ERCP- or PTCS-directed PDT + stent placement can prolong the survival of patients with unresectable hilar cholangiocarcinoma, especially those with recurrence and improve quality of life without increasing adverse events.

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Mitomycin, Ifosfamide, and Cisplatin in Unresectable Non–Small-Cell Lung Cancer: Effects on Survival and Quality of Life

Journal of Clinical Oncology ◽

10.1200/jco.1999.17.10.3188 ◽

1999 ◽

Vol 17 (10) ◽

pp. 3188-3194 ◽

Cited By ~ 350

Author(s):

M. H. Cullen ◽

L. J. Billingham ◽

C. M. Woodroffe ◽

A. D. Chetiyawardana ◽

N. H. Gower ◽

...

Keyword(s):

Quality Of Life ◽

Lung Cancer ◽

Palliative Care ◽

Small Cell Lung Cancer ◽

Survival Time ◽

Median Survival ◽

Median Survival Time ◽

Small Cell ◽

Small Cell Lung

PURPOSE: Chemotherapy for non–small-cell lung cancer (NSCLC) remains controversial. We describe the two largest reported, randomized, parallel trials designed to determine whether the addition of chemotherapy influences duration and quality of life in localized, unresectable (mitomycin, ifosfamide, cisplatin [MIC]1 trial) and extensive (MIC2 trial) disease. PATIENTS AND METHODS: Ambulatory patients with NSCLC, aged 75 years or younger, with localized disease, were randomized in MIC1 to receive up to four cycles of chemotherapy (CT: mitomycin 6 mg/m2, ifosfamide 3 g/m2, and cisplatin 50 mg/m2) every 21 days, followed by radical radiotherapy (CT + RT) or radiotherapy (RT) alone. Extensive-stage patients were randomized in MIC2 to identical chemotherapy plus palliative care (CT + PC) or palliative care (PC) alone. Short-term change in quality of life (QOL) was assessed in a subgroup of patients. Data from the two trials were combined to allow multivariate and stratified survival analyses. RESULTS: Seven hundred ninety-seven eligible patients were randomized, 446 in MIC1 and 351 in MIC2. MIC CT improved survival in both trials (significantly in MIC2). The median survival time in MIC1 was 11.7 months (CT + RT) versus 9.7 months (RT alone) (P = .14); whereas in MIC2, median survival time was 6.7 months (CT + PC) compared with 4.8 months (PC alone) (P = .03). QOL, assessed in 134 patients from start of trial to week 6, showed improvement with chemotherapy and deterioration with standard treatment. In the combined analysis of 797 randomized patients, the positive effect of MIC on survival was significant overall (P = .01) and after adjusting for prognostic factors (P = .01). CONCLUSION: MIC chemotherapy prolongs survival in unresectable NSCLC without compromising QOL.

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Silikon-Stents nach endobronchialer Tumorabtragung: Benefit bleibt ungewiss

Karger Kompass Pneumologie ◽

10.1159/000509155 ◽

2020 ◽

Vol 8 (4) ◽

pp. 202-203

Author(s):

Lars Hagmeyer

Keyword(s):

Quality Of Life ◽

Stent Placement ◽

Stent Insertion ◽

Stent Group ◽

First Line ◽

Extrinsic Compression ◽

Silicone Stent ◽

Line Chemotherapy

Background: Therapeutic bronchoscopy (TB) is an accepted strategy for the symptomatic management of central airway malignant obstruction. Stent insertion is recommended in case of extrinsic compression, but its value in preventing airway re-obstruction after endobronchial treatment without extrinsic compression is unknown. Objective: Silicone stent Placement in symptomatic airway Obstruction due to non-small cell lung Cancer (SPOC) is the first randomized controlled trial investigating the potential benefit of silicone stent insertion after successful TB in symptomatic malignant airway obstruction without extrinsic compression. Method: We planned an inclusion of 170 patients in each group (stent or no stent) over a period of 3 years with 1-year follow-up. The 1-year survival rate without symptomatic local recurrence was the main endpoint. Recurrence rate, survival, quality of life, and stent tolerance were secondary endpoints. During 1-year follow-up, clinical events were monitored by flexible bronchoscopies and were evaluated by an independent expert committee. Results: Seventy-eight patients (mean age 65 years) were randomized into 2 arms: stents (n = 40) or no stents (n = 38) after IB. Consequently, our main endpoint could not be statistically answered. Improvement of dyspnea symptoms is noticeable in each group but lasts longer in the stent group. Stents do not change the survival curve but reduce unattended bronchoscopies. In the no stent group, 19 new TB were performed with 16 stents inserted contrasting with 10 rigid bronchoscopies and 3 stents placed in the stent group. In a subgroup analysis according to the oncologic management protocol following TB (firstline treatment and other lines or palliation), the beneficial effect of stenting on obstruction recurrence was highly significant (p < 0.002), but was not observed in the naïve group, free from first-line chemotherapy. Conclusion: Silicone stent placement maintains the benefit of TB after 1 year on dyspnea score, obstruction’s recurrence, and the need for new TB. Stenting does not affect the quality of life and is suggested for patients after failure of first-line chemotherapy. It is not suggested in patients without previous oncologic treatment.

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Comparison of Survival and Quality of Life in Advanced Non–Small-Cell Lung Cancer Patients Treated With Two Dose Levels of Paclitaxel Combined With Cisplatin Versus Etoposide With Cisplatin: Results of an Eastern Cooperative Oncology Group Trial

Journal of Clinical Oncology ◽

10.1200/jco.2000.18.3.623 ◽

2000 ◽

Vol 18 (3) ◽

pp. 623-623 ◽

Cited By ~ 433

Author(s):

Philip Bonomi ◽

KyungMann Kim ◽

Diane Fairclough ◽

David Cella ◽

John Kugler ◽

...

Keyword(s):

Quality Of Life ◽

Survival Time ◽

Median Survival ◽

Median Survival Time ◽

Eastern Cooperative Oncology Group ◽

Small Cell ◽

Oncology Group ◽

Small Cell Lung ◽

Dose Levels

PURPOSE: Treatment with cisplatin-based chemotherapy provides a modest survival advantage over supportive care alone in advanced non–small-cell lung cancer (NSCLC). To determine whether a new agent, paclitaxel, would further improve survival in NSCLC, the Eastern Cooperative Oncology Group conducted a randomized trial comparing paclitaxel plus cisplatin to a standard chemotherapy regimen consisting of cisplatin and etoposide. PATIENTS AND METHODS: The study was carried out by a multi-institutional cooperative group in chemotherapy-naive stage IIIB to IV NSCLC patients randomized to receive paclitaxel plus cisplatin or etoposide plus cisplatin. Paclitaxel was administered at two different dose levels (135 mg/m2 and 250 mg/m2), and etoposide was given at a dose of 100 mg/m2 daily on days 1 to 3. Each regimen was repeated every 21 days and each included cisplatin (75 mg/m2). RESULTS: The characteristics of the 599 patients were well-balanced across the three treatment groups. Superior survival was observed with the combined paclitaxel regimens (median survival time, 9.9 months; 1-year survival rate, 38.9%) compared with etoposide plus cisplatin (median survival time, 7.6 months; 1-year survival rate, 31.8%; P = .048). Comparing survival for the two dose levels of paclitaxel revealed no significant difference. The median survival duration for the stage IIIB subgroup was 7.9 months for etoposide plus cisplatin patients versus 13.1 months for all paclitaxel patients (P = .152). For the stage IV subgroup, the median survival time for etoposide plus cisplatin was 7.6 months compared with 8.9 months for paclitaxel (P = .246). With the exceptions of increased granulocytopenia on the low-dose paclitaxel regimen and increased myalgias, neurotoxicity, and, possibly, increased treatment-related cardiac events with high-dose paclitaxel, toxicity was similar across all three arms. Quality of life (QOL) declined significantly over the 6 months. However, QOL scores were not significantly different among the regimens. CONCLUSION: As a result of these observations, paclitaxel (135 mg/m2) combined with cisplatin has replaced etoposide plus cisplatin as the reference regimen in our recently completed phase III trial.

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Efficacy and safety of endoscopic radiofrequency ablation for unresectable extrahepatic cholangiocarcinoma: a randomized trial

Endoscopy ◽

10.1055/s-0043-124870 ◽

2018 ◽

Vol 50 (08) ◽

pp. 751-760 ◽

Cited By ~ 26

Author(s):

Jianfeng Yang ◽

Jing Wang ◽

Haibin Zhou ◽

Yifeng Zhou ◽

Yang Wang ◽

...

Keyword(s):

Radiofrequency Ablation ◽

Adverse Events ◽

Survival Time ◽

Hilar Cholangiocarcinoma ◽

Palliative Treatment ◽

Stent Group ◽

Stent Patency ◽

Extrahepatic Cholangiocarcinoma ◽

Type Iii ◽

Significant Difference

Abstract Background Endoscopic placement of biliary stents to relieve jaundice is the main palliative treatment for unresectable extrahepatic cholangiocarcinoma. Endoscopic biliary radiofrequency ablation (RFA) has been reported to prolong stent patency, which may be beneficial in improving patient survival. However, available evidence is still insufficient, as most reported studies are retrospective case series. The aim of this study was to explore the clinical effect and safety of RFA in patients with unresectable extrahepatic cholangiocarcinoma. Methods 65 patients with unresectable extrahepatic cholangiocarcinoma, except Bismuth type III and IV hilar cholangiocarcinoma, were enrolled and randomly underwent either RFA combined with biliary stenting (RFA + stent group; n = 32) or biliary stent only (stent-only group; n = 33). Overall survival time, stent patency period, and postoperative adverse events were recorded. Results In the 21-month follow-up period, the overall mean survival time was significantly longer in the RFA + stent group than in the stent-only group (13.2 ± 0.6 vs. 8.3 ± 0.5 months; P < 0.001). The mean stent patency period of the RFA + stent group was also significantly longer than that of the stent-only group (6.8 vs. 3.4 months; P = 0.02). There was no significant difference in the incidence of postoperative adverse events between the two groups (6.3 % [2/32] vs. 9.1 % [3/33]; P = 0.67). Conclusion Endoscopic RFA combined with stenting can significantly prolong survival and the stent patency period without increasing the incidence of adverse events in patients with extrahepatic cholangiocarcinoma patient, except Bismuth type III and IV hilar cholangiocarcinoma. This approach can be considered as a safe and effective palliative treatment for these patients.

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Increased survival time or better quality of life? Trade-off between benefits and adverse events in the systemic treatment of cancer

Clinical & Translational Oncology ◽

10.1007/s12094-019-02216-6 ◽

2019 ◽

Vol 22 (6) ◽

pp. 935-942 ◽

Cited By ~ 3

Author(s):

V. Valentí ◽

J. Ramos ◽

C. Pérez ◽

L. Capdevila ◽

I. Ruiz ◽

...

Keyword(s):

Quality Of Life ◽

Adverse Events ◽

Survival Time ◽

Systemic Treatment ◽

Trade Off

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The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.4052 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 4052-4052 ◽

Cited By ~ 1

Author(s):

Richard Malthaner ◽

Edward Yu ◽

Michael Susmoy Sanatani ◽

Debra Lewis ◽

Andrew Warner ◽

...

Keyword(s):

Quality Of Life ◽

Esophageal Cancer ◽

Adverse Events ◽

Surgical Resection ◽

Gastroesophageal Junction ◽

Trimodality Therapy ◽

Significant Difference ◽

Resectable Esophageal ◽

One Year

4052 Background: We compared the health-related quality-of-life (HRQOL) of standard neoadjuvant cisplatin and 5-FU chemotherapy plus radiotherapy (N) followed by surgical resection to adjuvant cisplatin, 5-FU, and epirubicin chemotherapy with concurrent extended volume radiotherapy (A) following surgical resection for resectable esophageal carcinoma. Methods: 96 patients with stage I to III resectable cancer of the esophagus were enrolled into a prospective randomized trial (NCT00907543) from April 2009 to November 2016. Patients were randomized into 2 groups: N (47 cases) and A (49 cases). The primary end point was HRQOL using the FACT-E at one year. The secondary endpoints included other HRQOL measures, overall survival (OS), disease-free survival (DFS), and adverse events. Results: The median follow-up was 5.0 years [95% CI :4.6 to 5.5]. The majority of patients had adenocarcinomas of the distal esophagus/gastroesophageal junction (80.9% vs 87.8%). The stage distribution was: I 9%; II 22%; III 58%; TxN0-1 10%. Using an intention-to-treat analysis there was no significant difference in the FACT-E total scores between arms at one year (p = 0.759), with 35.5% vs. 41.2% respectively showing an increase of ≥ 15 points ( a priori minimal clinical difference) compared to pre-treatment (p = 0.638). The HRQOL was temporarily significantly inferior at 2 months in the N arm for FACT-E, EORTC OG25, and EQ-5D-3L in the dysphagia, reflux, pain, taste, and coughing domains (p < 0.05). There were no 30-day mortalities but 2.1% vs. 10.2% 90-day mortalities (p = 0.204). There were no significant differences in either 5-year OS (37.9% vs 28.9%, p = 0.321) or DFS (34.0% vs 25.5%, p = 0.551. 48.9% of patients required chemotherapy to be modified or stopped in the N arm compared to 57.1% in the A arm (p = 0.421). 51.1% of patients were able to complete the prescribed N arm chemotherapy without modification compared to only 14.3% in the A arm (p < 0.001). Chemotherapy related adverse events significantly more frequent in the neoadjuvant arm (p < 0.05). Surgery related adverse events were significantly more frequent in the neoadjuvant arm (p < 0.05). Conclusions: Trimodality therapy is challenging for patients with resectable esophageal cancer regardless if it is given before or after surgery. Less toxic protocols are needed. Clinical trial information: 00907543.

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Improvements in multiple domains of quality of life with alemtuzumab as assessed by the functional assessment of multiple sclerosis questionnaire over 6 years regardless of presence of thyroid adverse events

10.26226/morressier.5b7578655aff7400151f35ff ◽

2018 ◽

Author(s):

Aaron Boster

Keyword(s):

Quality Of Life ◽

Multiple Sclerosis ◽

Adverse Events ◽

Functional Assessment ◽

Multiple Domains

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Faculty Opinions recommendation of A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results.

Faculty Opinions – Post-Publication Peer Review of the Biomedical Literature ◽

10.3410/f.717969214.793469111 ◽

2013 ◽

Author(s):

Marc Chamberlain

Keyword(s):

Quality Of Life ◽

Brain Metastases ◽

Solid Tumors ◽

Surgical Resection ◽

Whole Brain Radiotherapy ◽

Phase Iii ◽

Phase Iii Trial ◽

European Organisation ◽

Brain Radiotherapy

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Proton Pump Inhibitors in 2021: Pros, Cons, and Everything in Between

Foregut: The Journal of the American Foregut Society ◽

10.1177/26345161211021766 ◽

2021 ◽

pp. 263451612110217

Author(s):

Joshua A. Sloan ◽

Philip O. Katz

Keyword(s):

Quality Of Life ◽

Side Effects ◽

Adverse Events ◽

Proton Pump Inhibitors ◽

Proton Pump ◽

Drug Class ◽

Life Threatening

The medical and lay literature has exploded with reports of adverse events associated with proton pump inhibitors over the last 10 to 15 years. The dissemination of these reports to patients and clinicians have created substantial concerns regarding what has been an exceptionally valuable drug class, dramatically improving patient quality of life, and in many cases preventing life threatening side effects of other medication. Patients are more frequently seeking to avoid these medications, and practitioners are reducing or discontinuing them to the patient’s detriment due to a misunderstanding of the data. This review will discuss the data regarding the most commonly publicized adverse events and attempt to put them in perspective.

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