Tumor response to neoadjuvant chemotherapy predicts long-term survival outcomes in patients with locoregionally advanced nasopharyngeal carcinoma: A secondary analysis of a randomized phase 3 clinical trial

14023 Background: Response to neoadjuvant treatment is vital to predict a patient’s long-term survival. Precise detection of residual tumor cells after neoadjuvant chemotherapy would allow a better cosmetic results avoiding over surgery and reduce second operation due to positive margin status. Moreover, accurate prediction of pathological CR will yield no surgical intervention in certain population. Recently, a new generation of ultrasound platforms with real-time freehand elastography that enables the imaging of elasticity of the lesion by using the extended combined autocorrelation method (CAM) has become available. We are currently applying this technology to our patients with primary breast cancer in an attempt to assess response to neoadjuvant chemotherapy in comparison with MRI, conventional ultrasound and pathological findings. Methods: A total of 38 patients with primary breast cancer who underwent neoadjuvant chemotherapy and following surgical resection From May 2005 to Dec 2006 were included in this study. Board certified radiologists assessed the tumor response by MRI, US and US Elastography prior to surgery. Positive predictive value (PPV), and negative predictive value (NPV) for pathological CR (pCR) was assessed. Tsukuba Elastography score was applied for the assessment of Elastography. Results: 11/38 patients (28.9%) achieved a pCR in breast to neoadjuvant chemotherapy while no patients demonstrated progressive disease. The PPV for pCR of MRI and US was 54.5% and 36.3% respectively. The NPV of MRI and US was both 90.9%. None of the residual tumor mass with score 4 or 5 cases diagnosed by Elastography achieved pCR. When residual tumor image was detected by US, pCR was present in all 4 cases with score 1 or 2 Elatography. If the cut-off line is determined between score 3 and 4, the PPV and NPV for pCR by Elastography was 100% and 66.6% respectively. Conclusions: Elastography is easy to perform and it can provide an inexpensive, non-invasive, real-time tool for assessment of response to neoadjuvant chemotherapy among patients with primary breast cancer. In particular, Elastography might more effectively diagnose pathological CR. More patients are needed to evaluate the sensitivity and specificity of this new technology. No significant financial relationships to disclose.

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RETROSPECTIVE ANALYSIS OF LONG-TERM SURVIVAL OUTCOMES OF PRIMARY CYTOREDUCTION AND NEOADJUVANT CHEMOTHERAPY IN PATIENTS WITH OVARIAN CANCER STAGE IIIC–IV

Malignant tumours ◽

10.18027/2224-5057-2018-8-3-86-94 ◽

2018 ◽

Vol 8 (3) ◽

pp. 86-94 ◽

Cited By ~ 1

Author(s):

A. S. Tjulandina ◽

A. A. Rumyantsev ◽

K. Y. Morkhov ◽

V. M. Nechushkina ◽

S. A. Tjulandin

Keyword(s):

Ovarian Cancer ◽

Neoadjuvant Chemotherapy ◽

Retrospective Analysis ◽

Low Frequency ◽

Progression Free Survival ◽

Long Term Results ◽

Survival Outcomes ◽

Stage Iiic ◽

Term Survival

The choice of treatment strategy in patients with stage IIIC‑IV ovarian cancer (OC) remains the subject of numerous discussions. The reason for this is the unsatisfactory results of randomized trials and the low frequency of primary complete debulking surgery in these studies. We conducted a retrospective analysis to evaluate the survival outcomes in patients with OC stage IIIC–IV (n=314) who underwent treatment between 1995 and 2017. The median progression free survival for primary surgery was 15.6 months, after interval debulking – 11.5 months (p=0.002, HR 0.61: 95 % CI 0.39–0.81). The primary cytoreduction significantly increased the median of overall survival by 19.6 months: from 38.0 months after interval debulking up to 57.6 months after primary cytoreduction (p=0.04, HR 0.64: 95 % CI 0.41–0.99). An increase in the number of optimal interval debulking does not lead to an improvement in the long-term results of treatment in the group of patients after neoadjuvant chemotherapy. Our analysis over the past 20 years has shown that improvement in treatment outcomes is only observed in the primary cytoreduction group due to an increase in the number of complete optimal cytoreductive surgery.

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Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicenter randomized controlled trial.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.6004 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. 6004-6004 ◽

Cited By ~ 2

Author(s):

Ming-Yuan Chen ◽

Qi Yang ◽

Minghuang Hong ◽

Ming-Huang Hong

Keyword(s):

Clinical Trial ◽

Nasopharyngeal Carcinoma ◽

Induction Chemotherapy ◽

Concurrent Chemoradiotherapy ◽

Long Term Results ◽

Phase 3 ◽

Free Survival ◽

Multicenter Randomized Controlled Trial

6004 Background: Initial 3-year results from our clinical trial in locoregionally advanced nasopharyngeal carcinoma (NPC) patients showed that induction chemotherapy (IC) with cisplatin and fluorouracil (PF) resulted in improved disease-free survival (DFS) with a marginally significant effect on distant metastasis-free survival (DMFS), but the effect of IC on locoregional relapse-free survival (LRRFS) and overall survival (OS) did not differ significantly. Here, we present 5-year follow-up results. Methods: Our trial was a randomized, open-label phase 3 trial comparing IC followed by concurrent chemoradiotherapy (CCRT) versus CCRT alone in patients with stage III-IVB (except T3N0-1) NPC. The IC followed by CCRT group received cisplatin (80 mg/m² d1) and fluorouracil (800 mg/m² d1-5) every three weeks for two cycles before CCRT. Both groups were treated with 80 mg/m² cisplatin every three weeks concurrently with radiotherapy. The primary endpoints were DFS and DMFS. We did efficacy analyses in the 476 randomized patients (intention-to-treat population). Results: After a median follow-up of 82.6 months, the 5-year DFS rate was 73.4% (95% confidence interval (CI) 67.7-79.1) in the IC followed by CCRT group and 63.1% (95% CI 56.8-69.4) in the CCRT alone group (P = 0.005). The 5-year DMFS rate was also significantly higher in the IC followed by CCRT group (82.8%, 95% CI 77.9-87.7) than in the CCRT alone group (73.1%, 95% CI 67.2-79.0, P = 0.013). Our updated analysis revealed an OS benefit of IC: the 5-year OS rate was 80.8% in the IC followed by CCRT group versus 76.8% in the CCRT alone group (P = 0.045). There were no significant differences in the rate of grade 3–4 late adverse events during follow-up between the two groups. Conclusions: IC followed by CCRT provides long-term DFS, DMFS, and OS benefits compared with CCRT alone in locoregionally advanced NPC and, therefore, can be recommended for these patients. Clinical trial information: NCT00705627.

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Long-term outcomes of a prospective single institution study with multiagent chemotherapy and stereotactic body radiation therapy in locally advanced or recurrent pancreatic adenocarcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.3_suppl.440 ◽

2021 ◽

Vol 39 (3_suppl) ◽

pp. 440-440

Author(s):

Colin Hill ◽

Lauren M. Rosati ◽

Hao Wang ◽

Hua-Ling Tsai ◽

Shuchi Sehgal ◽

...

Keyword(s):

Clinical Trial ◽

Radiation Therapy ◽

Stereotactic Body Radiation Therapy ◽

Locally Advanced ◽

Survival Outcomes ◽

Term Survival ◽

Free Survival ◽

Stereotactic Body Radiation ◽

Multi Agent

440 Background: We previously reported a multi-center study in which gemcitabine and stereotactic body radiation therapy (SBRT) were shown to be safe with outcomes comparable to chemoradiation in locally advanced pancreatic cancer (LAPC). This prospective clinical trial was developed to evaluate the efficacy of adding SBRT to multi-agent chemotherapy in LAPC. Herein, we report on the long-term survival outcomes. Methods: From 2012 to 2015, 48 patients (pts) were prospectively enrolled after multidisciplinary evaluation at a single high-volume pancreatic center. Pts received multi-agent chemotherapy (CTX) with modified mFOLFIRINOX (mFFX) or gemcitabine/abraxane followed by 5 fractions of SBRT (median 33 Gy; range, 25-33 Gy). At the time of fiducial placement, biopsies were obtained and DNA extracted for targeted sequencing using MSK-IMPACT. Kaplan-Meier curves were generated to compare survival outcomes by sub-group. Multivariate analysis (MVA) was performed to identify factors prognostic for survival. Results: 44 pts (91.7%) had LAPC disease and 4 (8.3%) had locally recurrent disease. The median follow-up interval was 21.5 months (mo) from diagnosis. CTX consisted of mFFX in 25 pts (52.1%) with 24 pts (50.0%) receiving therapy for a duration ≥4 mo. Of 44 pts with LAPC, 15 (34.1%) were surgically explored, and 11 (73.3%) achieved a margin-negative resection. From diagnosis and after completion of SBRT, respectively, the median overall survival (OS) was 21.6 (95% CI 16-29.7 mo) and 14.6 mo (95% CI: 11.6-23.0 mo); median progression free survival (PFS) was 13.2 (95% CI 11.9-18.1mo) and 6.4 mo (95% CI: 5-12.7 mo); median local PFS (LPFS) was 23.9 (95% CI 18.9-56.9 mo) and 15.8 mo (95% CI: 12.9-27.6 mo); and median distant metastasis free survival (DMFS) was 18.4 (95% CI 12.6-29.3 mo) and 8.5 mo (95% CI: 6.3-17.2 mo). Resected pts experienced better DMFS at 1-year (78% vs. 34%, p= 0.004) with an improved trend for 1-year OS (73% vs. 52%, p= 0.331). If CTX duration was ≥4 mo, 1-year OS (75% vs. 42%, p= 0.018), PFS (50% vs. 21%, p= 0.022), and DMFS (72% vs. 29%, p= 0.031) were significantly improved. In 44 LAPC pts, MVA confirmed ≥4 mo duration of CTX was associated with OS, PFS, and DMFS. Surgical resection was associated with improved DMFS, and CA19-9 level prior to SBRT was associated with PFS and LPFS. The most common mutations detected from biopsy specimens were KRAS (64.3%) , TP53 (50%), and SMAD4 (16.7%). Conclusions: In a prospective trial of pts with LAPC receiving multiagent CTX and SBRT, clinical outcomes were improved with longer durations of CT ( > 4 mo). A high proportion of LAPC pts underwent margin negative resection with favorable outcomes. Future studies should focus on which pts are most likely to benefit from SBRT and surgery following multiagent CTX. In pts who cannot undergo resection, escalated doses of SBRT may be indicated. Clinical trial information: NCT01781728.

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