Inoperable Squamous Cell Carcinoma Research Articles

Comparison of Outcome of Concurrent Chemoradiotherapy and Sequential Chemoradiotherapy in Locally Advanced, Inoperable Squamous Cell Carcinoma of Head and Neck Region

Background: Head and neck cancer is prevalent in Bangladesh, with a majority of patients presenting with locally advanced, inoperable disease. This study aimed to compare the effectiveness and accessibility of concurrent and sequential (CCRT with RT) chemoradiotherapy in treating this condition, addressing a debate among oncologists. Materials and Methods: A quasi-experimental study at Rajshahi Medical College Hospital (June 2019 - May 2020) involved 60 inoperable head and neck cancer patients, comparing concurrent chemoradiotherapy with Cisplatin and sequential chemoradiotherapy with Paclitaxel and Cisplatin, monitoring treatment response and toxicities. Results: The mean age was 56.1 (±9.5) years in Arm-A and 56.9 (±9.4) years in Arm-B. The primary endpoint was loco-regional control and early toxicities. In the final response, 14 weeks after the completion of treatment, the overall loco-regional control rate was 86.67% and 76.67% in Arm-A and Arm-B, respectively. Severe toxicities include grade 3 reaction only and happened 18(58%) vs 13(42%) in Arm-A and Arm-B, respectively. Among severe toxicities, mucositis and skin reaction were higher in the concurrent Arm and anemia and neutropenia were higher in the sequential Arm. However, there was no actual difference in the two treatment modalities (p=>0.05). The overall treatment time was short in concurrent chemoradiotherapy (49 vs 133 days) and lower treatment cost as well, which was statistically significant (p=<0.0001). Conclusion: concurrent chemoradiotherapy proves cost-effective and accessible, demonstrating outcomes similar to sequential chemoradiotherapy. It stands as a viable treatment choice for locally advanced, inoperable head and neck squamous cell carcinoma.

Comparison of response and toxicity of induction chemotherapy with cisplatin and 5-fluorouracil versus cisplatin and paclitaxel followed by concurrent chemoradiotherapy in advanced head and neck cancer

Background: Head and neck cancer poses a prevalent oncological challenge in Bangladesh, often diagnosed in advanced stages. Standard treatment for inoperable cases involves concurrent chemo-radiotherapy, but induction chemotherapy has shown significant benefits. This study aimed to compare the response and toxicity of induction chemotherapy with cisplatin and 5-fluorouracil versus cisplatin and paclitaxel followed by concurrent chemo-radiotherapy in advanced head and neck cancer. Methods: From January 2019 to June 2020, a multicenter study enrolled 150 cases with inoperable squamous cell carcinomas in the head and neck. Ethical approval was obtained from Bangabandhu Sheikh Mujib Medical University. Divided into two arms, Arm A had 75 patients receiving cisplatin and 5-fluorouracil, while Arm B had 75 patients receiving cisplatin and paclitaxel for three cycles. Results: After 24 weeks of treatment, complete response rates were 53.33% in Arm A and 56.0% in Arm B, with partial response rates of 29.33% and 32.0% respectively. Overall response was 82.66% in Arm A and 88.0% in Arm B, showing no statistically significant difference (p>0.05). Arm A exhibited more anemia, oral mucositis, skin toxicity, and hand- foot syndrome, while Arm B had higher neuropathy. Hematological and non-hematologic toxicities during concurrent chemo-radiotherapy were similar in both arms. Conclusions: Induction chemotherapy with cisplatin and paclitaxel, followed by concurrent chemo-radiotherapy, is equally effective as induction chemotherapy with cisplatin and 5-fluorouracil, followed by concurrent chemo-radiotherapy, in treating advanced head and neck squamous cell carcinoma. However, the former regimen demonstrates significantly fewer toxicities, indicating a safer treatment option.

Metachronous Multiple Primary Inoperable Squamous Cancer of the Esophagus: Case Report

The incidence of primary multiple malignant neoplasms (PMMN) in Russia is steadily increasing due to the increasing frequency of detection of metachronous tumors. A similar trend is observed in esophageal cancer (EC). Advances in the diagnosis and treatment of cancer have led to an increase in the life expectancy of patients after a cured primary tumor and, in turn, to an increase in the detection rate of a second tumor. The longer life expectancy of patients with cancer, the higher the likelihood of developing a second tumor. PMMN of the esophagus is one of the least studied problems in modern oncology, which complicates the choice of treatment tactics, since there are no standards for the management of such patients. This article reflects a multidisciplinary and individual approach to the treatment of a patient with primary multiple metachronous inoperable squamous cell carcinoma of the middle and lower thoracic esophagus. The patient underwent chemoradiotherapy (CRT) with full effect, with no post-radiation damage and improved quality of life.

Experience of successful use of immunotherapy in treatment of locally advanced inoperable squamous cell carcinoma of the hairy part of the head

This article presents the experience of successful use of immunotherapy in treatment of locally advanced inoperable squamous cell carcinoma of the hairy part of the head.

A PROSPECTIVE AND COMPARATIVE STUDY ON CONCURRENT RADIOTHERAPY WITH GEFITINIB VERSUS RADIOTHERAPY ALONE IN THE TREATMENT OF ELDERLY PATIENTS WITH CARCINOMA OESOPHAGUS

Objective: Concurrent chemoradiotherapy (CTRT) is the primary treatment for inoperable carcinoma esophagus. However, elderly patients are often not capable of tolerating CTRT, leaving radiotherapy as only option available for them. Many studies showed efficacy of anti-EGFR agent Gefitinib with acceptable toxicity profile in carcinoma esophagus patients. Hence, in this study, we compared radiation along with Gefitinib against radiation alone for the treatment of inoperable esophageal carcinoma in elderly patients in terms of locoregional control and toxicity profile. Methods: Patients of 50–70 years age group with inoperable squamous cell carcinoma esophagus were randomized in two groups – the control group received external beam radiotherapy 50.4 Gy in two phases over 5 weeks and the study group received radiotherapy with same dose along with Tab Gefitinib-250 mg daily during the radiotherapy. Response assessment was done after completion of treatment and all patients were followed up weekly during the course of treatment and then at every month for at least 6 months. Results: Overall response rate (complete+partial response) was better in study arm (80% vs. 70%), but not statistically significant (p=0.221). Just after treatment completion dysphagia of grade2 and above was more in control arm but after 3 months there was rise in incidences of dysphagia in study arm (66.6% vs. 60% p=0.632). Although statistically not significant, gefitinib containing study arm showed more incidences of higher grade of diarrhoea (20% vs. 15%, p=0.843) and moderate to severe grade of anaemia (90% vs. 66%, p=0.921). Conclusion: We can say that concomitant treatment with Gefitinib and radiotherapy was well tolerated and effective in elderly patients of inoperable carcinoma esophagus.

Immediate Results of Concurrent Chemoradiotherapy with Inoperable Esophageal Squamous Cell Carcinoma

Background: The incidence of esophageal cancer is increasing. In this connection, the search for the most effective methods of treating this disease continues. In most patients, esophageal cancer is diagnosed at III– IV stages of the disease. Currently, the standard of treatment for inoperable patients is chemo radiotherapy. Brachytherapy is one of the perspective methods of radiation therapy. Using of brachytherapy in the complex treatment of patients with esophageal cancer makes possible to increase the radiation dose without increasing the risk of complications after treatment.Methods: The study included 20 patients with inoperable esophageal cancer (most of them with III stages, 60 %). The age of the patients is from 51 to 89 years, ECOG performance status ½ (25 %/75 %), dysphagia score 1/2/3–4 (25 %,50 %, 25 %). All patients were diagnosed with esophageal squamous cell carcinoma. Most patients were with tumor in the middle third of the esophagus (70 %). The greatest length of the tumor was 10 cm. On the first stage of treatment patients underwent external-beam radiation therapy 46 Gy in 2 Gy fractions with simultaneous chemotherapy. After that, brachytherapy was performed (single dose of 5 Gy, 2 fractions with an interval of 6–7 days, 62,8 Gy (EQD2, α/β = 10 Gy).Results: Patients received therapy support for cardiovascular and lung diseases and nutritional support before, during and following chemoradiotherapy. There were no patients with hematological toxicity grade 3–4. Esophagitis grade 2 was noted in 40 % of patients, grade 1 in 60 % of patients. Esophagitis resolved on its own 2 weeks after completion of therapy. Complete tumor regression was observed in 10 % of patients, partial regression in 80 % of patients, stabilization of tumor process was observed in 10 % of patients. All patients have a poor QOL due to physical and psychological disorders. The general health situation and physical function after 3 months of treatment was improved compared to the prior to treatment period.

Factors associated with inoperable cutaneous squamous cell carcinoma.

Inoperable cutaneous squamous cell carcinomas (SCCs) are rare and life-threatening, but few studies have investigated their causal factors. Our aim was to determine factors associated with inoperable SCCs, as well as patient and tumour characteristics, and care pathway-related factors. Based on an observational retrospective study at Reims University Hospital, France, the characteristics of tumours and patients were recorded based on 73 cases of inoperable SCCs and compared with 73 cases of operable SCCs. In addition, the clinical history and care pathway associated with inoperable cases was documented. In patients with inoperable SCCs, the median overall survival (OS) time was 7.6 months and the three-year OS was <5%. Compared to patients with operable tumours, those with inoperable tumours were older (83 vs 78.9; p = 0.018) and more frequently had a history of senile dementia (21.9% vs 8.2%; p = 0.048), cardiovascular disease (75.3% vs 50.7%; p = 0.009) or a tumour with poor or moderate differentiation (30.9% vs 13.3%; p= 0.04). A long delay between tumour appearance and first consultation with a dermatologist (median: five months), failing to attend further medical or surgical appointments (21%), initial refusal of surgery (18%), reluctance to accept doctors' recommendations by the family and/or patient (26%), and absence of surgical revision after a previous incomplete excision (29%) were identified as potentially modifiable factors associated with inoperable SCCs. There is a need for better information for both patients and doctors concerning the potential severity of SCCs and the importance of early and appropriate management, specifically in older and frail patients.

Re-irradiation with concurrent and maintenance nivolumab in locally recurrent and inoperable squamous cell carcinoma of the head and neck: A single-center cohort study

BackgroundThe rate of loco-regional recurrences for locally advanced head and neck squamous cell carcinoma (HNSCC) following standard treatment reaches up to 50%, accompanied by a probability of 20% to develop a second primary tumor in the head and neck region. MethodsTen patients with inoperable, in-field recurrence of HNSCC following previous primary or adjuvant radiotherapy (RT) in combination with concurrent platinum-based chemotherapy were re-irradiated with 60 Gray in 30 fractions between December 2017 and January 2020 with concurrent and maintenance nivolumab administration. Data were retrospectively collected and compared with patients who underwent re-irradiation (ReRT) with concurrent cisplatin following propensity score matching (PSM). Local progression-free survival (LPFS) and overall survival (OS) were visualized using Kaplan-Meier method (log-rank test). ResultsAll patients completed ReRT. Median number of applied courses of nivolumab was 12 (range, 3–38). OS rate was 50% at 12 months and the median OS was 11 (range, 2–23) months. Six and 12 month LPFS rates were 60% and 30%, respectively. Median LPFS was 8 (range, 2–19) months. OS and LPFS rates were not inferior to those of patients treated with concurrent cisplatin. No unexpected radiation-related toxicity occurred. A total of four patients developed any-grade immune-related adverse events of which two presented with grade 3 toxicities. One patient died within 3 weeks after ReRT. Higher blood levels of CRP (p = 0.004), lower levels of hemoglobin (p = 0.029) and higher neutrophil/lymphocyte ratio (p = 0.004) were associated with impaired LPFS. Higher recursive portioning analysis (RPA) class was associated with impaired LPFS (p = 0.022) and OS (p = 0.024). ConclusionThe combination of ReRT and nivolumab for locally recurrent HNSCC was feasible without occurrence of unexpected toxicities. Combined radioimmunotherapy might offer an effective treatment option for carefully selected pre-irradiated patients ineligible for salvage surgery.

Palliative intraarterial chemoradiotherapy as a method of choice in the treatment of unresectable oropharyngeal tumors: a clinical case

Introduction. Surgery is frequently preferable to therapy as it yields longer overall and recurrence-free survival. But surgery of locally advanced tumors of the oral cavity can not always guarantee preservation of oral functions. In the EORTC 24971 and RTOG 90-03 trials, effectiveness of conventional radiotherapy was demonstrated. Addition of brachytherapy allowed to double recurrence-free and overall survival. Implementation of proton therapy increased treatment safety. However, high cost of modern technology for radiotherapy limits its accessibility. Intra-arterial chemotherapy is characterized by lower toxicity. Additionally, it allows to create a pool for the 1st cycle of systemic circulation directly in the tumor and neighboring tissues, and a significant portion of the drug enters the draining lymph node replicating lymphogenic metastasis.The objective was to present a clinical case of successful treatment of inoperable squamous-cell carcinoma of the oropharynx using intra-arterial chemoradiotherapy.Clinical case. A patient sought medical help at the multidisciplinary clinical medical center “Medical City” where combination treatment was chosen: a course of chemoradiation therapy using an original approach combining external beam 3D-conformal radiotherapy and intraarterial chemotherapy. According to control computed tomography data, dynamics was described as partial response: 30 % reduction in marker lesions. The patient did not have any complaints and evaluated their quality of life as high which corresponded to the testing results.Conclusion. We have demonstrated benefits of intra-arterial chemoradiation therapy: low toxicity allows patients to receive a full course of radiotherapy without breaks and achieve high functional results. Considering palliative status of the patient, we did not aim to increase recurrence-free period but the objective of ensuring satisfactory quality of life was achieved. New, more physiological regimens of intra-arterial infusion will improve pharmacokinetic profile of chemotherapeutic drugs and will allow to achieve positive results.

Induction chemotherapy with docetaxel, cisplatin and cetuximab versus docetaxel, cisplatin and 5-fluorouracil followed by radiotherapy with cetuximab for locally advanced or inoperable squamous cell carcinoma of the head and neck: Promising results of a randomized phase II AGMT-trial.

6027 Background: Induction chemotherapy (ICT) with Cisplatin (P), 5-FU (F) and Taxanes (T) is a therapeutical option in patients suffering from locally advanced or unresectable stage III or IV squamous cell carcinoma of the head and neck (SCCHN). The role of ICT is controversial and toxicity and/or delay of radiotherapy may reduce the potential benefit of this treatment regimen. Here we report promising results of a randomized phase II trial comparing TPF with TP and Cetuximab (C) replacing F. Methods: In our trial, N= 100 patients with locally advanced or unresectable stage III or IV SCCHN were randomly assigned to either Arm A ( N= 49), receiving TPF, or Arm B ( N= 51), receiving TPC, both followed by radiotherapy (RT) + C. The primary end-point of the study was overall response rate (ORR) three months after RT + C was finished. Results: We observed a remarkable response rate (CR + PR) of 86.4% in the TPC-arm that compared favorably with 77.5% responding patients in the TPF-arm three months after RT + C was completed. OS and PFS were similar in both arms. After 400 days we observed an OS rate of 79% in the TPF and 86% in the TPC arm, and a PFS rate of 67% in the TPF and 70% in the TPC arm. TPC containing ICT led to less serious adverse events (SAEs), including blood and lymphatic disorders (40.8% in TPF arm, 27.5% in TPC arm) and metabolism and nutrition disorders (22.4% in TPF arm, 9.8% in TPC arm) during ICT. Interestingly, in HPVp16 positive patients, 88.24% in the TPF-arm and 93.33% in the TPC-arm showed CR or PR three months after RT + C, whereas only 69.57% in the TPF-arm and 82.76% in the TPC-arm showed CR or PR. We only lost one patient because of treatment-related mortality (TRM) and no delay from the end of ICT to local radiotherapy was observed in any patient. All patients received RT + C within three weeks after ICT was completed. Conclusions: In conclusion, TPC is a feasible and tolerable therapy regimen and can be applied within one day with less hematological toxicities. In contrast, more local reactions were observed after TPC. TPC containing ICT leads to improved response rates, while OS and PFS were similar in both arms. TRM was extremely low with 1%. Therefore, we conclude, that TPC containing ICT could be a considerable therapeutical alternative for patients with locally advanced or unresectable stage III or IV SCCHN, who are eligible for ICT. Clinical trial information: 2011-005540-99.

Comparative analysis between induction chemotherapy combined with concurrent chemoradiotherapy and chemoradiotherapy alone for thoracic esophageal squamous cell carcinoma

Objective To compare the clinical efficacy and safety between induction chemotherapy (IC) followed by concurrent chemotherapy (CRT) and CRT alone in patients with inoperable thoracic esophageal squamous cell carcinoma (ESCC). Methods Between 2002 and 2015, clinical data of 267 thoracic ESCC patients undergoing definitive CRT based on docetaxel combined with cisplatin were retrospectively analyzed. Through a matched case-control study, 85 patients receiving IC combined with CRT were matched to those undergoing CRT alone at a ratio of 1vs.1, according to age, gender, performance status, tumor location, tumor length, and TNM staging as the matching factors. Clinical efficacy and safety between two groups were statistically compared. Kaplan-Meier survival analysis was used to analyze the survival. The log-rank test was adopted to examine within-group differences. The Cox regression model was used for multivariate analysis. Results The median follow-up time for 170 patients was 18 months (range, 3-72 months). The overall objective response rates in the IC and CRT groups were 74.1% and 58.8%(P=0.035). The 3-year overall survival (OS) and progress-free survival (PFS) rates in the IC group were 44.2% and 34.8%, significantly higher than 29.7% and 15.4% in the CRT group (P=0.028, P=0.015). Subgroup analysis revealed that patients responsive to IC obtained significantly better OS (P=0.002), PFS (P=0.001), and local recurrence-free survival (LRFS)(P=0.002) compared with the IC non-responder, whereas the distant metastasis-free survival (DMFS) did not significantly differ (P=0.166). The incidence rate of grade 3–4 leukopenia in the IC group was significantly higher than that in the CRT group (38.8% vs. 24.7%, P=0.048). Multivariate analysis revealed that age and the addition of IC were independent prognostic factors for OS (P=0.003, 0.016). Conclusions Compared with concurrent CRT, IC in combination with CRT can yield better short-term efficacy and longer survival for ESCC patients. The risk of hematological toxicity in the IC group is relatively higher but tolerable. Prospective randomized trials are required to confirm the clinical efficacy and safety of IC for thoracic ESCC patients. Key words: Esophageal neoplasms/concurrent chemoradiotherapy; Induction chemotherapy; Prognosis

Brief palliative radiotherapy course for advanced and incurable head and neck cancer

<strong>Purpose:</strong> Palliative radiotherapy schedule for inoperable Squamous cell carcinoma of head and neck (SCCHN) will evaluated in terms of palliation of cancer-related symptoms and acute toxicities.

Chemotherapy dosing and toxicity in a patient with muscular dystrophy

Chemotherapy dosing has traditionally been based on a body surface area (BSA) calculation despite BSA dosing being problematic in a number of conditions, such as renal failure, liver failure, obesity, and sarcopenia. This case highlights another condition in which BSA dosing is problematic. A 57-year-old man with limb-girdle muscular dystrophy presents with stage IIA inoperable squamous cell carcinoma of the lung. He is treated with chemotherapy and radiotherapy with curative intent but develops significant chemotherapy related toxicity affecting chemotherapy scheduling and dosing. Later, his cancer progresses, and he is commenced on palliative chemotherapy resulting in further significant chemotherapy toxicity. Sarcopenia is known to increase risk of chemotherapy toxicity. This case postulates that changes in muscle mass seen in muscular dystrophy increases risk of chemotherapy toxicity, similar to sarcopenia.

Review of chemotherapeutic approaches for operable and inoperable esophageal squamous cell carcinoma.

The predominant histological types of esophageal cancer are adenocarcinoma and squamous cell carcinoma. Since these two histological types present as different diseases in terms of their epidemiology, pathologenesis, and tumor biology, separate therapeutic approaches should be developed against each type. While surgical resection remains the dominant therapeutic intervention for patients with operable esophageal squamous cell carcinoma (ESCC), their high rates of tumor recurrence have prompted investigation of multimodality therapies that combine surgery with chemotherapy, radiotherapy, and chemoradiotherapy. In Japan, preoperative chemotherapy with cisplatin (CDDP) plus 5-fluorouracil (5-FU) followed by radical esophagectomy has been accepted as the standard therapeutic approach for resactable clinical Stage II/III ESCC. Similarly, the CDDP and 5-FU regimen has been accepted as the first-line treatment for metastatic and unresectable ESCCs in Japan. Thus, in Japan chemotherapy is an indispensable component of therapy for both resectable and unresectable ESCCs. This review discusses the current knowledge, rationale, and available data regarding chemotherapy for resectable and unresectable ESCCs.

P-067 Long term results of a prospective study of dose escalated volumetric modulated arc radiotherapy with concurrent chemotherapy in inoperable squamous cell carcinoma of esophagus

P-067 Long term results of a prospective study of dose escalated volumetric modulated arc radiotherapy with concurrent chemotherapy in inoperable squamous cell carcinoma of esophagus

A retrospective comparison of taxane and fluorouracil-based chemoradiotherapy in patients with inoperable esophageal squamous cell carcinoma.

e15561Background: To retrospectively compare taxane-based with fluorouracil-based chemoradiotherapy in terms of toxicity profiles, efficacy and survival in patients with inoperable esophageal cance...

Health-related quality of life in patients with metastatic, relapsed, or inoperable squamous cell carcinoma of the head and neck in India

The objective of this study was to evaluate changes in health related quality of life (HRQoL) in patients with metastatic head and neck (H&N) cancer randomized to receive metronomic (methotrexate and celecoxib) or cisplatin chemotherapy. Patients older than 18 years, with a Karnofsky Performance score of ≥70, and diagnosed with metastatic, locally advanced inoperable or recurrent head and neck (H&N) cancer not amenable to surgery or radiation were randomized (1:1) to receive metronomic or cisplatin chemotherapy. All patients were recruited from the Tata Memorial Hospital, Mumbai, India. In addition to demographic and baseline clinical characteristics, patients were asked to rate their HRQoL using the EORTC QLQ-C30 and the EORTC QLQ-H&N35 questionnaires (Indian versions) at baseline and at the end of each chemo cycle (every 3 weeks) till the end of study or early termination. Of the 110 patients screened, 87 agreed to participate in the study. Mean age of the study population was 47.5 years (S.D. ±10.04) for the metronomic group and 47.2 years (S.D. ±9.89) for the cisplatin group. Overall quality of life was not significantly different between the two treatment groups from baseline to end of treatment. However, there was a statistically significant improvement in Pain QLQ-C30 score from baseline to week 3 (OR = 3.14, p = 0.036) and week 6 (OR = 3.33, p = 0.034) in the metronomic arm compared with the cisplatin arm. In addition to improvements in survival, understanding the impact of treatment options on changes in HRQoL is important as it can aid physicians in making treatment and rehabilitation decisions for patients with advanced inoperable H&N cancer.

A prospective randomized phase II study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin), in patients with metastatic, relapsed or inoperable squamous cell carcinoma of head and neck

BackgroundCetuximab based treatment is the recommended chemotherapy for head and neck squamous cell cancers in the palliative setting. However, due to financial constraints, intravenous (IV) chemotherapy without cetuximab is commonly used in lesser developed countries. We believe that oral metronomic chemotherapy may be safer and more effective in this setting. MethodsWe conducted an open label, superiority, parallel design, randomized phase II trial comparing oral MCT [daily celecoxib (200mg twice daily) and weekly methotrexate (15mg/m2)] to intravenous single agent cisplatin (IP) (75mg/m2) given 3 weekly. Eligible patients had head and neck cancers requiring palliative chemotherapy with ECOG PS 0–2 and adequate organ functions who could not afford cetuximab. The primary end point was progression-free survival. Results110 Patients were recruited between July 2011 to May 2013, 57 randomized to the MCT arm and 53 to the IP arm. Patients in the MCT arm had significantly longer PFS (median 101days, 95% CI: 58.2–143.7days) compared to the IP arm (median 66days, 95% CI; 55.8–76.1days) (p=0.014). The overall survival (OS) was also increased significantly in the MCT arm (median 249days, 95% CI: 222.5–275.5days) compared to the IP arm (median 152days, 95% CI: 104.2–199.8days) (p=0.02). There were fewer grade 3/4 adverse effects with MCT, which was not significant. (18.9% vs. 31.4%, P=0.14). ConclusionOral metronomic chemotherapy has significantly better PFS and OS than single agent platinum in the palliative setting.

Induction Chemotherapy with Cisplatin and 5-Fluorouracil in Advanced Head and Neck Cancers: A Short Term Response Evaluation.

Considering the uprising number of Head and neck cancer in the state with limited options of medical and surgical treatment, the focus of this study involved on chemotherapy in advanced Head and neck cancers. The aim of this study was to evaluate the efficacy and toxicity of combination of Cisplatin and 5-Fluorouracil (PF) as induction chemotherapy in patients in locally advanced squamous cell cancer of head and neck. Forty four patients with previously untreated stage III -IV advanced and inoperable cases were included in this prospective study. Induction chemotherapy consisted of 3 cycles of Cisplatin 100mg/mt(2) as infusion on day 1, 5-Fluorouracil of 750mg/mt(2) on day 2, 5-Fluorouracil of 1000mg/mt2 as infusion on day 3 in an inpatient basis. Cycles were repeated with an interval of 21 days. Patients were evaluated within a period of 3 weeks at the end of completion of third cycle of chemotherapy. Post chemotherapy local therapy was individualized based on the response, site and stage of the tumour. Out of 44 eligible and evaluable patients, major dominance was noted in male group constituting 68%. After induction chemotherapy 58.8% of stage III experienced stable response, & 44% had partial response. In stage IV, 44% showed a stable response and 33.3% had partial response. But in comparison to primary tumour response and nodal response, which had a significant clinical response, the overall response of malignancy with respect to stage and site specificity was clinically insignificant. Moderate adverse reaction was noted in 47.6% and 42.1% had mild reactions. Majority of patients experienced grade 3 adverse events, of which anaemia in females and leucopenia in males pre-dominated. With the use of cisplatin and 5-FU as induction chemotherapy agents in advanced and inoperable squamous cell carcinoma of head and neck, a distinct benefit was seen in stabilizing the tumour from progression. But achieving a significant complete response to the same is of faint possibility. An alternate multidrug regimen or multimodality treatment would be ideal to gain the optimum results from induction agents. Toxicity related to chemotherapy usually is transient at therapeutic doses, and can be controlled by adequate prophylactic measures.

Nimotuzumab with Concurrent Chemo-Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of Head and Neck (LASCCHN)

Background: Head and neck cancers (HNCs) constitute 5% of all cancers globally and are the most common cancers in India. Chemotherapy and radiotherapy have not been proved to be effective in advanced cases and the prognosis remains dismal. This underscores the need for newer treatment options in these cases. Nimotuzumab, an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, was safer when combined with chemo- or radio-therapy. Aim: To evaluate the safety and efficacy of concurrently administered nimotuzumab with chemo-radiotherapy in patients with advanced inoperable squamous cell carcinomas of head and neck (LASCCHN). Methods: This was an open-label, single arm study evaluating 57 patients with histologically confirmed inoperable LASCCHN (stages III and IV) and eastern co-operative oncology group (ECOG) performance status 2 and IV nimotuzumab 200 mg weekly for 6 weeks, along with radiotherapy of 6600 cGy over 33 fractions. Patients were evaluated over response evaluation criteria in solid tumors (RECIST) criteria 24 weeks after the last cycle of chemotherapy. Results: Mean age of patient was 50 years old (29 - 79 years old). The most common site of cancer was oral cavity (56.1%). Forty six patients (80.7%) completed 6 cycles of therapy. Objective response rate (ORR) was 80.7%, with 34 patients (59.6%) achieving complete response (CR), and 12 (21%) achieving partial response (PR). Stable disease (SD) was noted in 8 (14%) patients and progressive disease in 3 (5.2%) patients. Conclusion: Addition of nimotuzumab is a safe and efficacious option in patients with inoperable LASCCHN. Our observations confirm the available Phase II data. The long term survival benefits based on this encouraging response rate need to be further evaluated in this subset of cancer patients.