Quality-adjusted survival with combination nab-paclitaxel + gemcitabine vs gemcitabine alone in metastatic pancreatic cancer: a Q-TWiST analysis

Reni, Michele; Yin, Wei; Solem, Caitlyn T; Whiting, Scott; Ji, Xiang; Botteman, Marc

doi:10.3111/13696998.2014.903122

Cited by 22 publications

(20 citation statements)

References 24 publications

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“…On the other hand, quality of life was not assessed in the MPACT trial. In contrast, GNP showed significant improvement in quality-adjusted survival in comparison to gemcitabine alone using the Quality-Adjusted Time Without Symptoms or Toxicities (Q-TWiST) methodology, despite the limitations of the Q-TWiST analysis and the lack of prospective quality of life data from the MPACT trial[8]. …”

Section: Toxicity and Quality Of Lifementioning

confidence: 99%

“…These modifications successfully maintained the efficacy of the drugs while significantly decreasing the toxicity profile (decreased neutropenia, vomiting and fatigue). Additional exploratory analyses of the MPACT trial showed that patients who had dose delays or reductions (71% and 41%, respectively) had better outcomes[8]. These practical changes are capable of modifying the tolerance profile of the drugs while preserving efficacy.…”

Section: Toxicity and Quality Of Lifementioning

confidence: 99%

“…More aggressive regimens were developed to overcome these resistance mechanisms. The combination of non-cross resistant agents, GTX (gemcitabine, docetaxel and capecitabine) and PEFG (cisplatin, epirubicin, fluorouracil and gemcitabine), enhanced tumor shrinkage by acting on different stages of cell cycle and bypassing mechanisms of drug resistance[6-8]. …”

Section: Introductionmentioning

confidence: 99%

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Dilemma of first line regimens in metastatic pancreatic adenocarcinoma

Ghosn¹,

Ibrahim²,

Assi³

et al. 2016

WJG

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Pancreatic cancer is one of the deadliest cancers, ranking fourth among cancer-related deaths. Despite all the major molecular advances and treatment breakthroughs, mainly targeted therapies, the cornerstone treatment of metastatic pancreatic cancer (mPC) remains cytotoxic chemotherapy. In 2016, more than 40 years after the introduction of gemcitabine in the management of mPC, the best choice for first-line treatment has not yet been fully elucidated. Two main strategies have been adopted to enhance treatment efficacy. The first strategy is based on combining non-cross resistant drugs, while the second option includes the development of newer generations of chemotherapy. More recently, two new regimens, FOLFIRINOX and gemcitabine/nab-paclitaxel (GNP), have both been shown to improve overall survival in comparison with gemcitabine alone, at the cost of increased toxicity. Therefore, the best choice for first line therapy is a matter of debate. For some authors, FOLFIRINOX should be the first choice in patients with an Eastern Cooperative Oncology Group score (0-1) given its lower hazard ratio. However, others do not share this opinion. In this paper, we review the main comparison points between FOLFIRINOX and GNP. We analyze the two pivotal trials to determine the similarities and differences in study design. In addition, we compare the toxicity profile of the two regimens as well as the impact on quality of life. Finally, we present studies revealing real life experiences and review the advantages and disadvantages of possible second-line therapies including their cost effectiveness.

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Section: Toxicity and Quality Of Lifementioning

confidence: 99%

Section: Toxicity and Quality Of Lifementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Dilemma of first line regimens in metastatic pancreatic adenocarcinoma

Ghosn¹,

Ibrahim²,

Assi³

et al. 2016

WJG

View full text Add to dashboard Cite

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“…A recent analysis assessing nab-paclitaxel plus gemcitabine combination treatment vs gemcitabine-only in first-line mPAC (Reni et al , 2014) found a 21% relative improvement in Q-TWiST in favour of the combination treatment over gemcitabine-only treatment. The Q-TWiST improvement observed in the current analysis for nal-IRI+5-FU/LV ( vs 5-FU/LV) was 24%.…”

Section: Discussionmentioning

confidence: 99%

Quality-adjusted survival with combination nal-IRI+5-FU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: a Q-TWiST analysis

et al. 2017

Self Cite

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Background:In the NAPOLI-1 Phase 3 trial, nal-IRI+5-fluorouracil and leucovorin (5-FU/LV) significantly improved median overall survival (6.1 vs 4.2 months, P=0.012) and progression-free survival (3.1 vs 1.5 months, P=0.0001) vs 5-FU/LV alone in metastatic pancreatic adenocarcinoma patients previously treated with gemcitabine-based therapy. This analysis evaluated between treatment differences in quality-adjusted time without symptoms of disease progression or toxicity (Q-TWiST).Methods:Overall survival was partitioned into time with grade ⩾3 toxicity (TOX), disease progression (REL), and time without disease progression symptoms or grade ⩾3 toxicity (TWiST). Mean Q-TWiST was calculated by weighting time spent by a utility of 1.0 for TWiST and 0.5 for TOX and REL. In threshold analyses, utility for TOX and REL were varied from 0.0 to 1.0.Results:Patients in nal-IRI+5-FU/LV (n=117) vs 5-FU/LV (n=119) had significantly more mean time in TWiST (3.4 vs 2.4 months) and TOX (1.0 vs 0.3 months) but similar REL (2.5 vs 2.7 months). In the base case, nal-IRI+5-FU/LV patients had 1.3 months (95% CI, 0.4–2.1; 5.1 vs 3.9) greater Q-TWiST (threshold analyses range: 0.9–1.6 months).Conclusions:Within NAPOLI-1, nal-IRI+5-FU/LV resulted in statistically significant and clinically meaningful gains in quality-adjusted survival vs 5-FU/LV alone.

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“…In recent phase III trials for metastatic pancreatic cancer, fluorouracil plus leucovorin plus irinotecan plus oxaliplatin (FOLFIRINOX) and gemcitabine plus albumin-bound paclitaxel (nab-paclitaxel) showed a clear benefit with respect to OS compared with gemcitabine alone 1 2. FOLFIRINOX also showed delayed HRQOL deterioration compared with gemcitabine alone,3 while gemcitabine plus nab-paclitaxel was associated with longer quality-adjusted survival than gemcitabine alone based on non-patient-reported health utilities 4. However, because of their associated toxicities,1 2 these two regimens require a good patient performance status and close monitoring 5 6.…”

Section: Introductionmentioning

confidence: 99%

Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study

Hagiwara

Ohashi

Okusaka³

et al. 2017

ESMO Open

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Objective:This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL.Methods:Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed.Results:Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference, −0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores.Conclusions:GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.

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Quality-adjusted survival with combination nab-paclitaxel + gemcitabine vs gemcitabine alone in metastatic pancreatic cancer: a Q-TWiST analysis

Cited by 22 publications

References 24 publications

Dilemma of first line regimens in metastatic pancreatic adenocarcinoma

Dilemma of first line regimens in metastatic pancreatic adenocarcinoma

Quality-adjusted survival with combination nal-IRI+5-FU/LV vs 5-FU/LV alone in metastatic pancreatic cancer patients previously treated with gemcitabine-based therapy: a Q-TWiST analysis

Health-related quality of life in a randomised phase III study of gemcitabine plus S-1, S-1 alone and gemcitabine alone for locally advanced or metastatic pancreatic cancer: GEST study

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