Use of Systemic Antineoplastic Drug Therapy after Regulatory Agency Approval

Markman, Maurie

doi:10.1159/000112730

Cited by 5 publications

(2 citation statements)

References 10 publications

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“…This is especially true after regulatory approval, where the doses of new oncology drugs used in daily practice often differ from the doses recommended in their prescribing information [10]. An observational study provides a useful tool for describing everyday clinical practice since in these trials the safety and efficacy of a drug in a non-selected group of patients from community practice is reported, providing evidence to support clinical trial findings.…”

Section: Introductionmentioning

confidence: 99%

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

Huober

Fett²,

Nusch³

et al. 2010

BMC Cancer

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BackgroundPegylated liposomal doxorubicin (PLD) is active in metastatic breast cancer. This observational study evaluated the efficacy and safety of PLD in patients treated during routine clinical practice.MethodsEligible patients had metastatic breast cancer and were treated with PLD according to the dose and schedule determined by their physician as part of routine practice. The primary objectives were to analyze the efficacy and toxicity of PLD therapy.Results125 patients were assessable. Median age was 62 years, 78% had performance status 0-1, and 60% had estrogen-receptor-positive disease. PLD treatment was second- or third-line in 69% of patients. Prior anthracyclines (adjuvant or metastatic) had been used in 56% of patients. The majority of patients (79%) received PLD every 4 weeks at a median dose of 40 mg/m2. Overall response rate was 43% in all patients and 34% in those previously treated with anthracyclines. The most common grade 3/4 adverse events were skin toxicity/hand-foot syndrome (6%), and leukopenia (3%).ConclusionsThis observational study supports the activity and tolerability of PLD in metastatic breast cancer as demonstrated in PLD clinical trials.

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Section: Introductionmentioning

confidence: 99%

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

Huober

Fett²,

Nusch³

et al. 2010

BMC Cancer

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“…Moreover, these trials were carried out in highly selected patients and under favorable protocol conditions. The results of these trials are difficult to apply to patients in everyday practice who may be older, have increased comorbidities, and may receive suboptimal chemotherapy regimens or doses (17,18). As a result, the efficacy of adjuvant chemotherapy observed in the meta-analysis may not be as great as the value in the off-protocol setting.…”

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confidence: 99%

The Effectiveness of Off-Protocol Adjuvant Chemotherapy for Patients with Urothelial Carcinoma of the Urinary Bladder

Svatek

Shariat

Lasky

et al. 2010

Clinical Cancer Research

129

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Purpose: The role of adjuvant chemotherapy for patients with high-risk urothelial carcinoma of the bladder (UCB) is not well defined. Here we address the value of adjuvant chemotherapy in patients undergoing radical cystectomy for UCB in an off-protocol routine clinical setting.Experimental Design: We collected and analyzed data from 11 centers contributing retrospective cohorts of patients with UCB treated with radical cystectomy without neoadjuvant chemotherapy. Patients were grouped into quintiles based on their risk of disease progression using estimates from a fitted multivariable Cox proportional hazards model. The association of adjuvant chemotherapy with survival was explored across separate quintiles.Results: The cohort consisted of 3,947 patients, 932 (23.6%) of whom received adjuvant chemotherapy. Adjuvant chemotherapy was independently associated with improved survival (hazard ratio, 0.83; 95% confidence interval, 0.72-0.97%, P = 0.017). However, the effect of adjuvant chemotherapy was significantly modified by the individual's risk of disease progression such that an increasing benefit from adjuvant chemotherapy was seen across higher-risk subgroups (P < 0.001). There was a significant improvement in survival between the treated and nontreated patients in the highest-risk quintile (hazard ratio, 0.75; 95% confidence interval, 0.62-0.90; P = 0.002). This group was characterized by an estimated 32.8% 5-year probability of cancer-specific survival, with 86.6% of patients having both advanced pathologic stage (≥T 3 ) and nodal involvement.Conclusion: Adjuvant chemotherapy is associated with a significant improvement in survival for patients treated in an off-protocol clinical setting. Selective administration in patients at the highest risk for disease progression, such as those with advanced pathologic stage and nodal involvement, may optimize the therapeutic benefit of adjuvant chemotherapy. Clin Cancer Res; 16(17); 4461-7. ©2010 AACR.

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Efficacy and toxicity profile of pegylated liposomal doxorubicin in patients with advanced ovarian cancer

Mayer

Brucker

Schuetz

et al. 2015

Arch Gynecol Obstet

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Use of Systemic Antineoplastic Drug Therapy after Regulatory Agency Approval

Cited by 5 publications

References 10 publications

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

A multicentric observational trial of pegylated liposomal doxorubicin for metastatic breast cancer

The Effectiveness of Off-Protocol Adjuvant Chemotherapy for Patients with Urothelial Carcinoma of the Urinary Bladder

Efficacy and toxicity profile of pegylated liposomal doxorubicin in patients with advanced ovarian cancer

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