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Annual Meeting Proceedings Part 1 - American Society of Clinical ...

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370s Head and Neck Cancer<br />

5556 General Poster Session (Board #23H), Sat, 1:15 PM-5:15 PM<br />

Organ preservation with daily concurrent chemoradiotherapy using a new<br />

superselective intra-arterial infusion for stage III, IV tongue cancer.<br />

Presenting Author: Iwai Tohnai, Department <strong>of</strong> Oral and Maxill<strong>of</strong>acial<br />

Surgery, Yokohama City University School <strong>of</strong> Medicine, Yokohama, Japan<br />

Background: Combined radiotherapy and intra-arterial chemotherapy, which<br />

delivers a very high concentration <strong>of</strong> anticancer agent to the tumor, is<br />

currently used to treat advanced head and neck cancer. However, chemotherapy<br />

and radiotherapy cannot be performed simultaneously on a daily<br />

basis under conventional methods because long-term catheterization is not<br />

possible. Therefore, we developed a new method using superselective<br />

intra-arterial infusions via the superficial temporal artery and the occipital<br />

artery, and used it to perform daily concurrent chemoradiotherapy for the<br />

treatment <strong>of</strong> advanced tongue cancer. Methods: Seventy-two patients with<br />

advanced tongue cancer underwent chemoradiotherapy using this superselctive<br />

intra-arterial infusion method. Catheters were inserted superselectively<br />

to the feeding arteries <strong>of</strong> the tumor via the superficial temporal artery<br />

and the occipital artery. Long-term catheterization is possible in this<br />

method. Daily concurrent combined therapy with radiotherapy (total dose:<br />

60 Gy), superselective intra-arterial chemotherapy using DOC (total dose:<br />

60 mg/m2 ) and CDDP (total dose: 150 mg/m2 ) was performed. The<br />

anticancer agent was injected in a bolus through the intra-arterial catheter<br />

simultaneously with radiotherapy. Results: No major complications were<br />

observed. <strong>Clinical</strong> efficacy was CR in 64 (88.9 %) patients and PR in 8<br />

(11.1 %). With a median follow-up period <strong>of</strong> 31 months (range 6 to 72<br />

months), the overall survive rate was 74.8 % and the local control rate was<br />

93.7%. Conclusions: This superselective intra-arterial infusion allows for<br />

long-term catheterization, unlike the conventional method, so that chemotherapy<br />

can be performed simultaneously with radiotherapy on a daily<br />

basis. This treatment method promises to be the strategy <strong>of</strong> choice for the<br />

treatment <strong>of</strong> advanced tongue cancer.<br />

5558 General Poster Session (Board #24B), Sat, 1:15 PM-5:15 PM<br />

Recombinant adenoviral human p53 gene combined with radio- and<br />

chemotherapy in treatment <strong>of</strong> advanced nasopharyngeal carcinoma: A<br />

randomized clinical study. Presenting Author: Guiping Lan, The People’s<br />

Hospital <strong>of</strong> Guangxi Zhuang Autonomous Region, Nanning, China<br />

Background: Studies showed p53 gene therapy could enhance the antitumor<br />

effect <strong>of</strong> both chemo- and radiotherapy. The anti-tumor function <strong>of</strong><br />

p53 gene is associated with up-regulated expression <strong>of</strong> p21 and Bax. Here,<br />

we investigate the beneficial role <strong>of</strong> recombinant adenoviral human p53<br />

gene (rAd-p53) combined with chemoradiotherapy in treatment <strong>of</strong> advanced<br />

nasopharyngeal carcinoma (NPC), and p21 and Bax protein<br />

expression in pre- and post-treatment tumor tissues. Methods: Sixty-three<br />

patients with historically-diagnosed advanced NPC, with ECOG performance<br />

status less than 2, life expectancy greater than 3 months and<br />

adequate organ function tests, were randomly assigned into two groups: 32<br />

in experimental group (EG) and 31 in control group (CG). EG received<br />

intratumoral injection <strong>of</strong> 1�1012 rAd-p53 viral particles (VP) per 3 days for<br />

6-8 times, carboplatin 300 mg/m2 on day1 and continuous infusion <strong>of</strong> a<br />

total dose <strong>of</strong> 2000 mg/m2 <strong>of</strong> 5-Fu on day1-5 for 3 cycles, and radiotherapy<br />

at a dose <strong>of</strong> 2Gy/fraction for a total dose <strong>of</strong> 70-76 Gy/35-38f. CG received<br />

the same chemo- and radiotherapy. Pre- and post-treatment tissue samples<br />

were analyzed for Bax and p21 protein levels. Results: The median<br />

follow-up time was 28 months. EG achieved a complete response rate (CR)<br />

<strong>of</strong> 62.5% and overall response rate (RR) <strong>of</strong> 90.6%, both rates being<br />

statistically significantly higher than that <strong>of</strong> CG (CR�35.5%, RR�74.2%).<br />

One-year <strong>of</strong> overall survival (OS) was 100.0% for EG and 90.3% for CG,<br />

and one year <strong>of</strong> progress free survival (PFS) was 96.7% and 77.4% for EG<br />

and CG, respectively. Two-year OS was 95.7% and 86.4% for EG and CG,<br />

respectively, and two-year <strong>of</strong> PFS was 79.6% and 73.5% for EG and CG,<br />

respectively. After treatment, both Bax and p21 protein levels in EG<br />

increased significantly. In CG, both proteins levels also increased after<br />

treatment but not significantly. The main side effects <strong>of</strong> rAd-p53 were<br />

self-limited fever, occurring in all <strong>of</strong> EG patients. Conclusions: RAd-p53 as<br />

a component <strong>of</strong> the comprehensive therapy for advanced NPC contributes<br />

significant beneficial effects. Increased levels <strong>of</strong> Bax and p21proteins after<br />

treatment represent two mechanisms <strong>of</strong> p53 anti-tumor activities.<br />

5557 General Poster Session (Board #24A), Sat, 1:15 PM-5:15 PM<br />

Gemcitabine versus cisplatin concurrent with radiation therapy in locally<br />

advanced head and neck squamous cell carcinoma. Presenting Author:<br />

Magda Mostafa, Kasr Al Aini Center <strong>of</strong> <strong>Clinical</strong> Oncology and Radiation<br />

Therapy (NEMROCK), Cairo, Egypt<br />

Background: In locally advanced head and neck squamous cell carcinoma<br />

(HNSCC) weekly cisplatin concurrent with radiation therapy is the standared<br />

treatment. However some patients cannot tolerate cisplatin. So we<br />

conduct a prospective randomized trial comparing cisplatin versus gemcitabine.<br />

Methods: This trial was done in Kasr El-Ainy Center <strong>of</strong> <strong>Clinical</strong><br />

Oncology and Radiation therapy (NEMROCK), during the period from<br />

March 2010 till June 2011. Sixty patients with locally advanced HNSCC<br />

were randomized to receive Cisplatin (30 mg/m2 ) weekly for 6 consecutive<br />

weeks (30 patients) or Gemcitabine (50 mg/m2 ) weekly for 6 consecutive<br />

weeks (30 patients) both concomitant with radiation therapy reaching a<br />

dose <strong>of</strong> 70 Gy over 7 weeks. Primary end points include response rate,<br />

progression free survival and toxicity. Toxicities were graded according to<br />

NCI-CTCAE v3.0. Results: Thewhole study group included 48 (80%) males<br />

and 12 (20%) females. Mean age was 47.9 (� 6.5) years (range 26-61).<br />

Both arms were comparable regarding their age, gender, performance<br />

status and stage. There were 9 (30%) CR, 7 (23.3%) PR, 2 (6.7%) SD and<br />

12 (40%) PD in cisplatin arm versus 12 (40%) CR, 4 (13.3%) PR, 1<br />

(3.3%) SD and 11 (36.7%) PD in gemcitabine arm. Median progression<br />

free survival (PFS) in cisplatin arm was 9 months versus 11months in<br />

gemcitabine arm with a hazard ratio <strong>of</strong> 0.08 (95% CI 0.005 – 1.47). We<br />

did not reach median overall survival. Radiotherapy induced skin toxicity<br />

(slight or patchy atrophy), nausea, vomiting, mucositis, salivary gland<br />

affection and weight loss were equally distributed in both arms. Dysphagia<br />

and fatigue were markedly higher in gemcitabine arm. While infection and<br />

neutropenia were slightly higher in cisplatin arm. Conclusions: Weekly<br />

gemcitabine 50mg/m2 concomitant with radiotherapy was found to be <strong>of</strong><br />

equal efficacy and toxicity comparable with weekly cisplatin in the<br />

treatment <strong>of</strong> locally advanced HNSCC.<br />

5559 General Poster Session (Board #24C), Sat, 1:15 PM-5:15 PM<br />

Outcomes <strong>of</strong> occult primary (OP) <strong>of</strong> the head and neck squamous cell<br />

carcinoma (HNSCC) treated with oropharynx (OPX)-targeted radiotherapy<br />

(RT) and concurrent chemotherapy (CCRT). Presenting Author: Kenneth<br />

Hu, Beth Israel Medical Center, New York, NY<br />

Background: OP <strong>of</strong> HNSCC is commonly treated with comprehensive<br />

mucosal RT including nasopharynx, OPX, hypopharynx and larynx and<br />

bilateral neck. We are reporting the long term outcomes <strong>of</strong> a conservative<br />

mucosal sparing technique consisting <strong>of</strong> targeting only the OPX mucosa<br />

and bilateral necks. Methods: This is a single-institution retrospective<br />

study. From January 1998-2010, a total <strong>of</strong> 68 patients with OP <strong>of</strong> HNSCC<br />

were treated with CCRT (90%) or RT alone (10%), 40% with IMRT. RT<br />

fields comprehended OPX mucosa only and bilateral necks. Gross disease<br />

in the neck received 70Gy, involved neck 63 Gy, OPX 60 Gy, uninvolved<br />

neck and ipsilateral retropharyngeal nodes 54 Gy. All fractions were given<br />

at the rate <strong>of</strong> 1.8-2 Gy/fraction. The median age was 58 (21-87), 80%<br />

Caucasian, and 75% males. Stage IVa (N2) was 75% <strong>of</strong> the population,<br />

while stages III (N1), and IVb (N3) were 9, and 16% respectively. 16<br />

patients (9N3�7 bulky N2) underwent neck dissection (ND). The median<br />

time interval from diagnosis to RT and RT duration were 60 (13-70) and 50<br />

days (49-63) respectively. The Median number <strong>of</strong> Chemotherapy cycles<br />

was 2 (1-3). Cisplatin was given to 70% <strong>of</strong> pts, while Carboplatin and<br />

Cetuximab were 10 and 20% respectively. Results: With a median follow-up<br />

<strong>of</strong> 5.3 years (1– 13.6), the loco-regional control, (LRC) for all stages is 95.6<br />

%. The median time to LRF is 18 months (12 - 63). Chronic CCRT toxicity<br />

was; grade (1) xerostomia (67%), dysphagia (35%), altered taste (28%),<br />

neck stiffness (15%), skin toxicity (12%), dysphonia (9%), and trismus<br />

(6%). One HIV patient developed grade 4 dysphagia. No patients experienced<br />

distant metastases. The emergence <strong>of</strong> primary was (1.5%) 1 patient<br />

developed subglottic SCC 2 years after CCRT, 2 patients failed in the neck<br />

(originally N3) all the 3 patients were salvaged successfully by surgery.<br />

Kaplan-Meier curve shows the 5-year cause-specific survival to be 100.<br />

Conclusions: Our data show that CCRT or definitive RT alone to the OPX and<br />

bilateral neck provides excellent oncologic and functional outcomes.<br />

Sparing the mucosal surfaces <strong>of</strong> the nasopharynx, hypopharynx, and larynx<br />

seems reasonable and likely reduces toxicity.<br />

Visit abstract.asco.org and search by abstract for the full list <strong>of</strong> abstract authors and their disclosure information.

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