Impact of a pre- and postoperative chemotherapy (Ctx) on overall survival (OS) and progression free survival (PFS) in locally advanced gastric cancer (LAGC).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 156-156
Author(s):  
Ricarda Manth ◽  
H Schaefer ◽  
J Schroeder ◽  
G Spiessl ◽  
N Nuessler ◽  
...  
Keyword(s):  
Internal Control ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Initial Therapy ◽  
Tumor Board ◽  
Free Survival ◽  
Locally Advanced Gastric Cancer ◽  
Primary Surgery ◽  
Secondary Endpoints

156 Background: Perioperative Ctx has become standard of care for LAGC. Duration of pre- and post-op Ctx is a matter of debate. Our study evaluated effects of varying durations of pre- and post-op Ctx on PFS and OS. Secondary endpoints were toxicity, reasons for cessation of Ctx and response. We compared the outcome to a group of pts receiving no perioperative Ctx as an internal control. Methods: Pts with LAGC were included in a prospective cohort trial from a single institution from 2007 to 2015. Inclusion criteria were T1-T4, N0-3, M0, AEG (n=27) or gastric cancers (n=65). Initial therapy decisions were made by an interdisciplinary tumor board for all pts. Pts received DDP/5-FU (qw d28 mod FFCD-Protocol, Ychou et al. JCO 2011) for 2 mo, and a 3rd mo of pre-op Ctx in case of non-progression after 2 mo and proceeded to Ctx after surgery for a planned total of six mo of Ctx. Results: 92 pts (53 m; 39 f pts) with a median age of 69 ys (range 33-96) were included. A total of 74 pts were recommended periop Ctx and 18 primary surgery (S). A total of 67 (91%) of the periop Ctx received pre-op Ctx (NA) of which 47 (64%) received 3 mo of pre-op Ctx, 19 (26%) two mo, 1 pt (1%) one mo, and 7 pts refused preop Ctx (9%) of which only 3 proceeded to surgery. Only 53 pts (72 %) received post-op Ctx; 25 pts (34%) received three mo, 9 pts (12 %) two mo, and another 10 pts (14 %) one mo of postop Ctx. Nine pts (13%) in the NA group and 20 pts (39%) in the post-op Ctx group had to stop Ctx due to toxicity after 1 (n=11) and <2 (n=9) mo of Ctx. Only 23 pts (31%) received the planned pre- and postop Ctx of 6 mo in total. Up to 07/2016 a total of 36 deaths were observed (39%). 5 yr PFS was 49% in the group of periop Ctx vs 14% in the S group. PFS in pts receiving a total of < 4 mo of Ctx was 36% vs. 61% in pts receiving 6 mo of Ctx. 3 yr OS was 19% in the S group vs 48% in the Ctx group. The OS in pts receiving < 4 mo was 34% vs.43% in pts with 6 mo Ctx. A pCR after preop Ctx was observed in 2 pts, a PR in 47 pts, a SD in 12 pts, while a PD occurred in 3 pts only. Conclusions: Pre-op Ctx was considerably better tolerated than post-op Ctx and led to fewer Tx cessations. We found a better PFS for pts with >4 mo of periop Ctx, as well as OS was affected by a shorter duration of periop Ctx.

scholarly journals Analysis of the efficacy and toxicity of sorafenib in thyroid cancer: a phase II study in a UK based population

2011 ◽  
Vol 165 (2) ◽  
pp. 315-322 ◽  
Author(s):  
Merina Ahmed ◽  
Yolanda Barbachano ◽  
Angela Riddell ◽  
Jen Hickey ◽  
Katie L Newbold ◽  
...  
Keyword(s):  
Thyroid Cancer ◽  
Thyroid Carcinoma ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Differentiated Thyroid Carcinoma ◽  
Free Survival ◽  
Hand Foot Syndrome ◽  
Secondary Endpoints ◽  
Radiological Response ◽  
Dose Reductions

AimTo evaluate the tolerability and efficacy of sorafenib in patients with thyroid carcinoma.MethodsPatients with progressive locally advanced/metastatic medullary thyroid carcinoma (MTC), or differentiated thyroid carcinoma (DTC) with non-radioiodine-avid disease, were treated with sorafenib 400 mg twice daily until disease progression. The primary endpoint was the radiological response rate (RR) at 6 months. Secondary endpoints were RR at 3, 9 and 12 months, biochemical responses, toxicity, biomarker analyses and progression free and overall survival (OS).ResultsA total of 34 patients were recruited to the study (15 medullary and 19 differentiated). After 6 months, the RR rate was 15% and a further 74% of patients achieved stable disease in the first 6 months. After 12 months of treatment, the RR was 21%. In the MTC patients, the RR at 12 months was 25% and OS was 100%. In DTC patients corresponding rates were 18 and 79% respectively. Median overall and progression-free survival points were not reached at 19 months. Commonest adverse events included hand–foot syndrome, other skin toxicities, diarrhoea and alopecia. Dose reduction was required in 79% patients. Median time on treatment was 16.5 months.ConclusionThis study demonstrates that sorafenib is tolerable at reduced doses over prolonged periods of time in patients with thyroid cancer. Sorafenib leads to radiological and biochemical stabilisation of disease in the majority of these patients despite dose reductions.

The selective personalized radioimmunotherapy for locally advanced NSCLC trial (SPRINT).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS8571-TPS8571 ◽  
Author(s):  
Nitin Ohri ◽  
Haiying Cheng ◽  
Shruti Jolly ◽  
Shirish M. Gadgeel ◽  
Benjamin Thomas Cooper ◽  
...  
Keyword(s):  
Performance Status ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Metabolic Tumor Volume ◽  
Disease Recurrence ◽  
Free Survival ◽  
Patient Reported ◽  
And Performance ◽  
New Diagnosis

TPS8571 Background: Concurrent chemoradiotherapy for locally advanced non-small cell lung cancer (LA-NSCLC) can cause significant toxicities, and disease recurrence after treatment is common. We previously demonstrated that a dose-painted radiotherapy approach provides excellent local disease control and has a favorable toxicity profile. Consolidation immunotherapy was recently shown to improve outcomes after chemoradiotherapy for LA-NSCLC, and pembrolizumab monotherapy is now a standard of care for patients with advanced high PD-L1-positive NSCLC. We hypothesize that dose-painted thoracic radiotherapy and immunotherapy without chemotherapy will be safe and effective for the treatment of biomarker-selected patients with LA-NSCLC. Methods: Patients with a new diagnosis of unresectable stage II or stage III NSCLC and performance status 0-1 will be enrolled on this phase II trial at one of three participating institutions. Twenty-five subjects with PD-L1 Tumor Proportion Score (TPS) of at least 50% will receive three cycles of induction pembrolizumab (200 mg every 3 weeks). Subjects then receive 20 fractions of dose-painted radiotherapy, where lesions with metabolic tumor volume exceeding 20 cc on FDG-PET receive a dose of 55 Gy, while smaller lesions receive a dose of 48 Gy. Subjects then receive 12 additional cycles of pembrolizumab. The primary endpoint is progression-free survival one year following study enrollment, which we hypothesize will be achieved for at least 65% of study subjects. Other endpoints include overall survival, distant metastasis-free survival, freedom from intrathoracic disease progression, adverse events, patient-reported outcomes, and physical activity metrics captured using wearable devices. In addition, we will explore markers of immune activation as prognostic factors. Approximately 38 patients with PD-L1 TPS below 50% will receive standard chemoradiotherapy and adjuvant therapy to serve as a contemporary comparison cohort. SPRINT is an innovative biomarker-driven study that explores a paradigm shift in the local and systemic therapy used to treat LA-NSCLC. This trial opened in August of 2018, and 5 subjects have been enrolled to date. Clinical trial information: NCT03523702.

Real-world outcomes in pancreatic adenocarcinoma (PDAC) and persona types with implications for standard of care (SOC) therapy (Tx).

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 735-735
Author(s):  
Emanuel Petricoin ◽  
Michael J. Pishvaian ◽  
Patricia DeArbeloa ◽  
Daniel Barg ◽  
Dzung Thach ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Standard Of Care ◽  
Tumor Board ◽  
Molecular Characteristics ◽  
First Line ◽  
Free Survival ◽  
Longitudinal Outcomes ◽  
Molecular Alterations ◽  
Deficiency Type ◽  
Improve Patient

735 Background: Molecular profiling (MP) for PDAC has gained increased acceptance and we previously demonstrated that targeting actionable mutations can improve patient (pt) outcomes. However, the correlations of diverse patterns of molecular alterations with outcomes following SOC Tx are largely unknown. Methods: We analyzed longitudinal outcomes of 1355 PDAC pts who underwent MP and received SOC Tx. “Persona” types were established based on the molecular characteristics of each pt using unsupervised clustering, as well as a supervised review defined by our molecular tumor board, following classifications reported in previous studies. Progression-free survival (PFS) for each type was assessed based on the choice of first-line Tx (i.e. FOLFIRINOX [FFX] vs. gemcitabine + nab-paclitaxel [GA]). Statistical comparisons were made against all other types within a specific Tx group. Results: The prognostic/predictive value of the persona types for 1st-line Tx revealed distinct differences in outcomes (Table). As expected, the DDR deficiency type was associated with a significantly improved PFS for pts treated with FFX but not for GA. In addition, pts in the cell cycle type had a worse PFS compared to other persona types for both FFX and GA. Using this platform, we will further subdivide the persona types into molecular subtypes and associate these with pt outcomes. Conclusions: Our analyses demonstrate that specific molecular persona types exist in PDAC pts and can be linked to Tx outcomes. Ultimately, knowing the persona type/subtype early in a pt’s Tx course may help personalize Tx to improve outcomes. [Table: see text]

scholarly journals Rationale and design of a phase II trial of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study)

2020 ◽  
Vol 12 ◽  
pp. 175883592092784 ◽  
Author(s):  
Tadaaki Yamada ◽  
Junji Uchino ◽  
Yusuke Chihara ◽  
Takayuki Shimamoto ◽  
Masahiro Iwasaku ◽  
...  
Keyword(s):  
Phase Ii ◽  
Antitumor Agents ◽  
Phase Ii Trial ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Stage Iii ◽  
Open Label ◽  
Free Survival ◽  
The Pacific ◽  
Secondary Endpoints

Background: In the PACIFIC study, progression-free survival (PFS) and overall survival (OS) of patients with unresectable, locally advanced, stage III non-small cell lung cancer (NSCLC) were prolonged by durvalumab as maintenance therapy after radical concurrent chemoradiotherapy using platinum-based antitumor agents. However, no data were obtained to reveal the efficacy of durvalumab after radiation monotherapy in patients unsuitable for chemoradiotherapy. Here, we describe an ongoing single-arm, prospective, open-label, multicenter phase II trial of durvalumab in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy (SPIRAL-RT study). Methods: Durvalumab at 10 mg/kg body weight is administered every 2 weeks after radiation therapy until individual patients meet the discontinuation criteria. The treatment duration is up to 12 months. The primary endpoint is the 1-year PFS rate. Secondary endpoints are response rate, PFS, OS, and safety. Durvalumab treatment after radiation monotherapy is expected to prolong 1-year PFS rate and have acceptable adverse events. Discussion: We are conducting an intervention study to investigate the safety and efficacy of durvalumab treatment in patients with NSCLC ineligible for stage III chemoradiotherapy following radiation monotherapy.

A randomized, open-label phase II study of nanoliposomal irinotecan (nal-IRI)-containing regimens versus nab-paclitaxel plus gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (mPAC).

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. TPS482-TPS482 ◽  
Author(s):  
Andrew Dean ◽  
Li-Tzong Chen ◽  
Ramesh K. Ramanathan ◽  
Sarah Blanchette ◽  
Bruce Belanger ◽  
...  
Keyword(s):  
Objective Response ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Primary Objective ◽  
Clinical Activity ◽  
First Line ◽  
Open Label ◽  
Free Survival ◽  
Open Label Phase ◽  
Secondary Endpoints

TPS482 Background: Two combination chemotherapy regimens have emerged as standard of care options for first-line treatment of mPAC: 5-fluorouracil (5-FU)/leucovorin (LV) + irinotecan + oxaliplatin (FOLFIRINOX), and nab-paclitaxel + gemcitabine. Nal-IRI (MM-398) is a nanoliposomal formulation of irinotecan. In a randomized phase 3 study (NAPOLI-1), of patients with mPAC who had been previously treated with gemcitabine-based therapy, nal-IRI + 5-FU/LV demonstrated its safety and significant clinical activity, increasing overall survival (OS) and progression-free survival (PFS) relative to 5-FU/LV. The goal of this current study is to determine the preliminary safety and efficacy of nal-IRI+ + 5-FU/LV with or without oxaliplatin as compared to nab-paclitaxel + gemcitabine in previously untreated patients with mPAC. Methods: This open-label, phase 2 comparative study will be conducted in two parts. Part 1 is a safety run-in of a nal-IRI+5-FU/LV + oxaliplatin regimen. The safety run-in will enroll small cohorts of patients following a traditional 3 + 3 dose escalation design to confirm the target dose of oxaliplatin (n = ~6-18). The primary objective of Part 1 is the safety and tolerability of nal-IRI + 5FU/LV + oxaliplatin. Part 2 is a randomized, efficacy study of a nal-IRI + 5-FU/LV + oxaliplatin regimen (Arm 1), the nal-IRI + 5-FU/LV combination that previously demonstrated efficacy in the NAPOLI-1 trial (Arm 2), versus a nab-paclitaxel + gemcitabine control arm (Arm 3) (n = ~156-168). The primary objective of Part 2 is to assess the efficacy of nal-IRI-containing regimens in first-line mPAC patients compared to nab-paclitaxel + gemcitabine using the progression-free survival (PFS) rate at 24 weeks as the primary endpoint. Secondary of part 1 is a PK study and Part 2 secondary endpoints will include OS, PFS, objective response rate (per RECIST, v1.1), decrease in CA19-9 levels and quality of life assessments. Clinical trial information: NCT02551991.

Retrospective review of stage III non-small cell lung cancer (NSCLC) patients treated with carboplatin/paclitaxel plus radiotherapy followed by docetaxel

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 18123-18123
Author(s):  
M. R. Patel ◽  
M. Weidner ◽  
J. W. Lynch ◽  
E. Walden ◽  
T. J. George
Keyword(s):  
Response Rate ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
Stage Iii ◽  
Consolidation Therapy ◽  
Free Survival ◽  
Phase Ii Studies ◽  
Unresectable Stage ◽  
Stage Iii Nsclc

18123 Background: Concurrent chemoradiotherapy is standard of care for unresectable patients and the most widely cited trials include the locally advanced multi-modality protocol (LAMP) study, SWOG S9019 and S9504. Our institutional approach represents a merger between the protocols utilized in two of these phase II studies: chemoradiotherapy from the LAMP study and consolidation therapy from SWOG S9504. Methods: We identified all stage III patients treated at the NF/SG VHS from Jan 2001 to Dec 2005. Eligible patients who had unresectable stage III NSCLC were included in the analysis. We treated 34 patients with weekly paclitaxel 45 mg/m2 plus carboplatin AUC 2 and concurrent TRT 63.0 Gy over 7 weeks. Four weeks after the completion of chemoradiotherapy, docetaxel 75 mg/m2 was given every 3 weeks for 21 days for 3 cycles as consolidation. Our primary endpoints were overall and progression free survival. The secondary endpoints were response rate and toxicity. Results: With a median age of 65 years and follow-up time of 25.9 months, median overall survival was 13.7 mos. Median progression free survival was 9.8 mos. The overall response rate was 68% including 5 CRs (15%). The most common grade 3/4 toxicities included pneumonitis (21%), esophagitis (21%), neutropenia (21%) [febrile neutropenia (9%)], neuropathy (18%), anemia (15%) and hypersensitivity to paclitaxel (9%). 62% of patients were able to complete the planned treatment. There were no treatment related deaths. At the time of this analysis, 9 patients were alive (26%) including 7 without progression (21%). Conclusions: Chemoradiotherapy with weekly carboplatin and paclitaxel followed by consolidation therapy with docetaxel is associated with comparable outcomes to other combined modality regimens. Given the advanced age and co-morbidities of our population, this regimen was generally well tolerated with the expected toxicities and can be considered as an option in the treatment of patients with unresectable stage III NSCLC. No significant financial relationships to disclose.

Randomized, blinded, placebo-controlled phase II trial of docetaxel and bavituximab as second-line therapy in locally advanced or metastatic non-squamous non-small cell lung cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 8095-8095 ◽  
Author(s):  
Mikhail Shtivelband ◽  
David R. Spigel ◽  
David E. Gerber ◽  
Minish Mahendra Jain ◽  
Olga V. Ponomarova ◽  
...  
Keyword(s):  
Locally Advanced ◽  
Vital Signs ◽  
Progression Free Survival ◽  
Disease Stage ◽  
Positive Trend ◽  
Free Survival ◽  
Phase 2 Trial ◽  
Secondary Endpoints ◽  
To Receive ◽  
Unacceptable Toxicity

8095 Background: Bavituximab (B) is a monoclonal antibody against phosphatidylserine (PS) with a selective tumor vascular-directed immune response. The purpose of this trial is to evaluate the efficacy and safety of B or placebo (P) combined with docetaxel (D) in patients with locally advanced or metastatic non-squamous NSCLC. Methods: Patients were randomized 1:1:1 to receive 75 mg/m2 of D every 21 days for up to 6 cycles combined with weekly blinded infusions of P, 1mg/kg B or 3 mg/kg B until disease progression or unacceptable toxicity. Primary efficacy endpoint was overall response rate (ORR). Secondary endpoints included progression free survival (PFS) and overall survival (OS). Safety was evaluated by adverse events (AEs), vital signs, CBC, biochemistry, urinalysis, coagulation, ECG. Post study unblinding, a PK substudy revealed vial coding discrepancies in the P and 1 mg/kg vials. As a result, data from these two groups were pooled to form the control (C) arm in the analysis. Results: Forty-one patients were entered into the 3mg/kg B+D arm and 80 into the control arm. No significant differences were seen in age, gender, ethnicity or disease stage. ECOG 2 was 13% in C and 24% in 3 mg/kg B+D arms. At this analysis, 54% death events have been reported in 3 mg/kg B+D and 71% in C arm. ORR is 17.1%/13.8% and median PFS is 4.5/3.3 months for 3 mg/kg B+D/C. Median OS is 11.7 months for 3 mg/kg B+D and 7.3 months for C. The safety profile for 3 mg/kg B+D was similar to that of C in severity and frequency. No other safety signal was identified. Conclusions: This randomized, placebo-controlled phase 2 trial demonstrated a positive trend favoring 3 mg/kg B+D in ORR, PFS and OS. 3 mg/kg B in combination with D was well tolerated and is the planned dose forPhase 3. Clinical trial information: NCT01138163.

scholarly journals Current FDA-Approved Therapies for High-Grade Malignant Gliomas

Biomedicines ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 324
Author(s):  
Jacob P. Fisher ◽  
David C. Adamson
Keyword(s):  
Controlled Trial ◽  
Malignant Gliomas ◽  
Progression Free Survival ◽  
Standard Of Care ◽  
High Grade ◽  
Tumor Treatment ◽  
Free Survival ◽  
Randomized Controlled ◽  
Significant Survival ◽  
One Year

The standard of care (SOC) for high-grade gliomas (HGG) is maximally safe surgical resection, followed by concurrent radiation therapy (RT) and temozolomide (TMZ) for 6 weeks, then adjuvant TMZ for 6 months. Before this SOC was established, glioblastoma (GBM) patients typically lived for less than one year after diagnosis, and no adjuvant chemotherapy had demonstrated significant survival benefits compared with radiation alone. In 2005, the Stupp et al. randomized controlled trial (RCT) on newly diagnosed GBM patients concluded that RT plus TMZ compared to RT alone significantly improved overall survival (OS) (14.6 vs. 12.1 months) and progression-free survival (PFS) at 6 months (PFS6) (53.9% vs. 36.4%). Outside of TMZ, there are four drugs and one device FDA-approved for the treatment of HGGs: lomustine, intravenous carmustine, carmustine wafer implants, bevacizumab (BVZ), and tumor treatment fields (TTFields). These treatments are now mainly used to treat recurrent HGGs and symptoms. TTFields is the only treatment that has been shown to improve OS (20.5 vs. 15.6 months) and PFS6 (56% vs. 37%) in comparison to the current SOC. TTFields is the newest addition to this list of FDA-approved treatments, but has not been universally accepted yet as part of SOC.

scholarly journals Treating the patient and not just the cancer: therapeutic burden in prostate cancer

2021 ◽  
Author(s):  
Daniel E. Spratt ◽  
Neal Shore ◽  
Oliver Sartor ◽  
Dana Rathkopf ◽  
Kara Olivier
Keyword(s):  
Prostate Cancer ◽  
Second Generation ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
Patient Treatment ◽  
Free Survival ◽  
Androgen Ablation ◽  
Therapeutic Benefits ◽  
Age Related ◽  
Concomitant Medications

Abstract Background Prostate cancer (PC) is a leading cause of death in older men. Androgen deprivation therapy (ADT) is considered the standard-of-care for men with locally advanced disease. However, continuous androgen ablation is associated with acute and long-term adverse effects and most patients will eventually develop castration-resistant PC (CRPC). The recent approval of three, second-generation androgen receptor inhibitors (ARIs), apalutamide, enzalutamide, and darolutamide, has transformed the treatment landscape of PC. Treatment with these second-generation ARIs have produced positive trends in metastasis-free survival, progression-free survival, and overall survival. For patients with non-metastatic CRPC, who are mainly asymptomatic from their disease, maintaining quality of life is a major objective when prescribing therapy. Polypharmacy for age-related comorbidities also is common in this population and may increase the potential for drug–drug interactions (DDIs). Method This review summarizes the multiple factors that may contribute to the therapeutic burden of patients with CRPC, including the interplay between age, comorbidities, concomitant medications, the use of ARIs, and financial distress. Conclusions As the treatment landscape in PC continues to rapidly evolve, consideration must be given to the balance between therapeutic benefits and potential treatment-emergent adverse events that may be further complicated by DDIs with concomitant medications. Patient-centered communication is a crucial aspect of alleviating this burden, and healthcare professionals (HCPs) may benefit from training in effective patient communication. HCPs should closely and frequently monitor patient treatment responses, in order to better understand symptom onset and exacerbation. Patients also should be encouraged to participate in exercise programs, and health information and support groups, which may assist them in preventing or mitigating certain determinants of the therapeutic burden associated with PC and its management.

Hyperfractionated Radiation Therapy With or Without Concurrent Low-Dose Daily Cisplatin in Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Prospective Randomized Trial

2000 ◽  
Vol 18 (7) ◽  
pp. 1458-1464 ◽  
Author(s):  
Branislav Jeremic ◽  
Yuta Shibamoto ◽  
Biljana Milicic ◽  
Nebojsa Nikolic ◽  
Aleksandar Dagovic ◽  
...  
Keyword(s):  
Squamous Cell Carcinoma ◽  
Radiation Therapy ◽  
Cell Carcinoma ◽  
Head And Neck ◽  
Squamous Cell ◽  
Low Dose ◽  
Locally Advanced ◽  
Progression Free Survival ◽  
High Grade ◽  
Free Survival

PURPOSE: To investigate whether the addition of cisplatin (CDDP) to hyperfractionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell carcinoma of the head and neck. PATIENTS AND METHODS: One hundred thirty patients were randomized to receive either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatment days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent low-dose (6 mg/m2) daily CDDP (group II, n = 65). RESULTS: Hfx RT/chemotherapy offered significantly higher survival rates than Hfx RT alone (68% v 49% at 2 years and 46% v 25% at 5 years; P = .0075). It also offered higher progression-free survival (46% v 25% at 5 years; P = .0068), higher locoregional progression-free survival (LRPFS) (50% v 36% at 5 years; P = .041), and higher distant metastasis-free survival (DMFS) (86% v 57% at 5 years; P = .0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grade RT-induced toxicity. Hematologic high-grade toxicity was more frequent in group II patients. CONCLUSION: As compared with Hfx RT alone, Hfx RT and concurrent low-dose daily CDDP offered a survival advantage, as well as improved LRPFS and DMFS.

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